Semaglutide being investigated for applications in heart disease, Alzheimer's, liver disease, and more
GLP-1 drugs expected to generate multi-hundreds of billions of revenues in the years to come
KELOWNA, BC / November 26, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following strategic update.
Today's GLP-1 drug market consists primarily of semaglutide (Wegovy®, Ozempic®, and Rybelsus®), owned by Novo Nordisk®; and tirzepatide (Zepbound®, Mounjaro®), owned by Eli Lilly™. All five of those drug brands, with the exception of Rybelsus®, are administered by injection, whereas Rybelsus® is the only oral tablet currently approved by the FDA today. While these two drugs were originally approved by the FDA for diabetes management, weight-loss approvals soon followed and Wegovy® was also approved by the FDA in March 2024 to reduce the risk of cardiovascular death, heart attack and stroke.
Acceptance and use of these two drugs by the public has resulted in unprecedented demand, with estimates of 2024 revenue between them of ~$30 billion, compared to just $300 million in 2018, an increase of 100x or 10,000%.
"The GLP-1 market may be the most significant development in pharmaceutical achievements of our lifetimes," said Richard Christopher, CEO of Lexaria. "Given the relatively early stage of investigation and development of these drugs, we simply do not know how big of an impact they will have, but it is safe to say that nearly every person in Europe or North America could experience improvement in their own health, or the health of a loved one, from GLP-1 drugs."
Some are asking whether this trend is a temporary one-off event and whether the recent revenue growth is sustainable; whereas there is a growing realization that - not only is this NOT a temporary event - future revenue growth is likely to be even stronger than that seen in recent years.
There are two main reasons for the growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year: one is that the patient population for diabetes, weight loss, and heart disease is massive and growing, with these drugs demonstrating good overall safety and efficacy. The other reason is that it seems quite likely that the therapeutic benefits from using these drugs is poised for significant expansion based on the evidence that is continually being updated.
Cardiovascular Disease
Recently, Novo Nordisk® announced that Rybelsus® demonstrated a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes, in a large Phase III trial of 9,650 people. With Wegovy® already FDA-approved for certain cardiovascular disease treatments, Novo Nordisk® will now be seeking FDA approval of Rybelsus® for similar use.
Liver Disease
There are currently no FDA-approved treatments for metabolic dysfunction-associated steatohepatitis ("MASH") liver disease, or for non-alcoholic fatty liver disease. GLP-1RAs have been reported to reduce liver fat content and liver enzymes, reduce oxidative stress and improve hepatic de novo lipogenesis and the histopathology of MASH. The MASH treatment market is forecasted to possibly reach $20 billion by 2032. Of the several leading pharmaceutical companies exploring treatment options for MASH, Pfizer is investigating its own GLP-1 molecule, danuglipron, as a potential daily tablet solution but is too early in its development to have received FDA approval at this time.
In 2020, Merck® agreed to pay up to $860 million in milestone payments to acquire the rights and licence to efinopegdutide, a GLP-1/GIP drug that was granted a Fast Track designation from the FDA in 2023 for the treatment of MASH.
Boehringer Ingelheim® has also been granted a Fast Track designation from the FDA for its molecule survodutide, yet another GLP-1 drug originally designed for application with obesity but now additionally being examined for certain liver diseases.
Sleep Apnea, Knee Pain
Following a Phase III study that showed an astonishing 63% reduction in apnea-hypopnea, Eli Lilly™ announced it would be seeking FDA approval for Zepbound® to be used for treating sleep apnea. Eli Lilly™ is also investigating its triple-agonist drug, retatrutide, for use in knee osteoarthritis as well as sleep apnea.
Not to be outdone, Novo Nordisk® has also reported that those who are overweight place additional stress on the knee and its protective cartilage and that in a study of 407 people diagnosed with knee arthritis, knee pain was reduced more thoroughly when those patients were treated with semaglutide than when they received a placebo.
Alzheimer's and Dementia
While GLP-1 drugs are known for triggering gastro-intestinal effects that create a sense of fullness, thus facilitating the treatment of obesity and diabetes, many investors have not yet realized that GLP-1 and related drugs have actions at main types of human brain receptors. Commercially available GLP-1 drugs have already shown an ability to bind with those receptors, but if and only if they are capable of crossing the blood-brain-barrier sufficiently upon administration. Lexaria has repeatedly shown, in previous studies with other drugs, that its DehydraTECH technology can at times improve the delivery of drugs into brain tissue. Lexaria's recently completed animal study WEIGHT-A24-1, is investigating for the brain absorption of DehydraTECH-processed GLP-1 drugs in study animals with data pending and expected to be released in either December, or in January, 2025.
Dulaglutide, owned by Eli Lilly™, is a GLP-1 drug that has shown a particular affinity to enter the brain, and, in a large human study of 8,828 participants, it has shown a significant benefit to cognition.
As well, liraglutide, owned by Novo Nordisk®, has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly 50% as compared to placebo. Semaglutide is also showing promising early-stage reduced risks against neurodegeneration and neuroinflammation.
Chronic Kidney Disease
Eli Lilly™ is conducting active research including a Phase II study expected to complete in early 2026, examining tirzepatide as a possible treatment for chronic kidney disease ("CKD"). If successful it is reasonable to expect Eli Lilly™ to progress to Phase III development and ultimately apply to the FDA for approval of the use of tirzepatide to treat this often life-threatening condition if successful.
Further, in a large analysis of over 165,000 patients, type-2 diabetic patients with acute kidney disease receiving GLP-1 drugs evidenced lower mortality rates and lower incidences of both major cardiovascular events and major adverse kidney events, than those patients not receiving GLP-1 drugs.
As well, Novo Nordisk® has earlier announced a successful outcome of a human trial of 3,533 people with CKD and type 2 diabetes using injected semaglutide. The study "demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24%."
Conclusion
The applications of GLP-1 and related drugs are still being identified. Given the widespread and rapid adoption of these drugs by tens of millions of people, data is being generated in real time at a scale never encountered before. The benefits of weight loss and diabetic control are obvious though not even close to being fully realized at this time, while the benefits in other areas of human health are still being discovered. Lexaria intends to continue research and development of its DehydraTECH drug delivery platform technology with as many GLP-1 and related drug molecules as it possibly can, in an attempt to identify broad areas of prospective commercial applicability for it to continue to participate in arguably the most exciting field of drug development in modern times.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format
KELOWNA, BC / November 25, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has been completed for human pilot study #3 (the "Study") investigating a DehydraTECH-processed version of the dual action glucagon-like peptide-1 ("GLP-1") + glucose-dependent insulinotropic peptide ("GIP") receptor agonist tirzepatide (sold commercially as Zepbound®) in an oral dose format.
The Study has been dosed in nine (9) healthy volunteers. The final seven-day dosing phase, wherein all subjects received the opposite treatment condition from that which they received during the initial dosing phase, was completed on November 16th. The initial dosing phase of either a seven-day regimen of oral DehydraTECH-processed tirzepatide capsules or a single injected tirzepatide dose was reported upon positively several weeks ago.
No serious adverse events have been observed thus far during both dosing visits, which serves as a point of interest given Lexaria's desire to create an effective oral version of Eli Lilly's™ tirzepatide products, which currently only exist in an injectable form.
The DehydraTECH composition for the Study was compound-formulated using the commercially available Zepbound® injectable formulation as the tirzepatide input material. Tolerability (side effects), blood absorption levels (pharmacokinetics or "PK"), and blood sugar control are being evaluated in the Study.
Tirzepatide is currently approved for use in the United States under the brand names Zepbound® and Mounjaro®, both owned by Eli Lilly™. These two brands combined are expected to generate approximately $15 billion in revenue in 2024. Eli Lilly™ recently announced that tirzepatide evidenced a 94% reduction in risk of progression to type 2 diabetes over a three-year study, and a reduction of 23% of bodyweight, on average, maintained for three years.
In two previous human pilot studies, Lexaria has evidenced that the oral administration of semaglutide (sold by Novo Nordisk® under the brands Rybelsus®, Ozempic®, and Wegovy®) processed with DehydraTECH yielded improvements in absorption rates and a reduction in both blood sugar and in adverse events, as compared to Rybelsus® tablets alone. The two drugs, semaglutide and tirzepatide, are believed to constitute over 90% of all revenue generated in the GLP-1 / GIP sector today.
Through the Study, Lexaria is attempting to evidence meaningful absorption rates of tirzepatide in an oral format, which is not available in the market today since it is currently administered only by injection. The Company expects that data analysis will occur in December with results available in January, 2025.
About the Study
Many design characteristics of the Study, also referred to as Study GLP-1-H24-3, are similar to Lexaria's initial GLP-1 human pilot study #1. The DehydraTECH-tirzepatide test articles were compound formulated using Zepbound®, strictly for research purposes, and dosed to the subjects under fasted conditions. The Study is designed to measure tolerability and side effects, blood levels of tirzepatide, and blood glucose levels. The DehydraTECH-tirzepatide composition was formulated at a strength of 20 mg tirzepatide administered orally daily for seven days. The Zepbound® formulation had a strength of 2.5 mg tirzepatide administered once via injection with the subject monitored over the same seven-day duration applicable with the oral DehydraTECH-tirzepatide condition. Blood samples were taken multiple times during the first 12 hours post dosing on the first day of each treatment phase, with a final blood draw taken 24 hours after dosing; and, a standardized meal was fed to the test subjects at a point in time after dosing. Single blood samples were also taken daily on each of the second through eighth days following commencement of each dosing visit. A total of 9 healthy subjects completed dosing with each test article following a randomized, cross over study design across two study phases.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation were the top performing groups in the Study outperforming the Rybelsus® control group in both body weight-loss, by 11.53% and 10.65% respectively, and in blood sugar, by 11.13% and 3.35% respectively.
DehydraTECH-semaglutide compositions with and without SNAC technology outperformed Rybelsus® control in body weight
Weight-control improvement demonstrated in ALL study groups during the final 4-weeks
Outcomes are strongly supportive of pending Phase 1b Australian human study
KELOWNA, BC / November 20, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received final 12-week body weight and blood sugar results from all 12 study groups of the recently completed diabetes animal study WEIGHT-A24-1 (the "Study").
The Study results were highlighted by the fact that all groups utilizing Lexaria's proprietary DehydraTECH technology outperformed Rybelsus® in body weight-control, as well as experienced body weight-control improvement during the final 4-weeks of the Study.
Furthermore, in all but group A, by week 12, the degree of improvement over Rybelsus® in body weight-control was statistically significant, p<0.05. Also of note were the top performing DehydraTECH-liraglutide and DehydraTECH-CBD groups (H and B). These groups outperformed the Rybelsus® control group by week 12 in body weight-control by 11.53% (p<0.0001) and 10.65% (p=0.0002) respectively and in blood sugar control by 11.13% (p=0.0395) and 3.35% (p=0.3853) respectively.
This Study was specifically designed to perpetuate a diabetic condition throughout the 12-week duration by offering the animals unlimited food and water, 24-hours per day, in order to examine and compare the relative performance of each Study group. It was not designed to maximize weight loss or blood glucose reduction and, therefore, its results should not be compared to third-party weight loss studies specifically optimized for those purposes. Accordingly, weight gain would not be an unexpected outcome of the Study, especially with orally administered glucagon-like peptide-1 ("GLP-1") drugs that are specifically designed to be taken by humans on an empty stomach after overnight fasting.
Study group "K" was a placebo wherein the animals only received water in lieu of any drug (the "Placebo Group"). The animals in the Placebo Group experienced an average weight gain of 1.40%, and an average increase in blood sugar of 10.33% over the Study duration. These are the benchmarks used for comparative purposes.
Study group "L" was a positive control wherein the animals received unadulterated Rybelsus® as the only FDA-approved oral GLP-1 drug on the market today, to utilize as a so-called "standard of care" (the "SOC Group"). The animals in the SOC Group experienced an average weight gain of 5.65%, and an average reduction in blood sugar of -0.41% over the Study duration.
All three of the DehydraTECH-semaglutide groups (E, F, and G) achieved superior body weight-control results throughout the duration of the Study than both the Placebo Group and the SOC Group. Notably, the DehydraTECH-semaglutide groups included formulations created using Rybelsus® as the semaglutide input (E and F) and a formulation created using pure semaglutide drug substance as the semaglutide input (G) without the salcaprozate sodium ("SNAC") technology integral to Novo Nordisk's commercially available Rybelsus® product performance.
Those same three groups (E, F, and G) achieved mostly superior blood sugar control results as compared to the Placebo Group throughout the duration of the Study and mostly superior blood sugar control results as compared to the SOC Group at the 4th and 8th week durations, but inferior results compared to the SOC Group by the 12th week duration.
Most of the DehydraTECH-CBD formulation groups (A, B, C, and D) achieved their best weight-control performance during the final 4 weeks of the Study, implying that a longer-term study may be required to determine the full extent of weight loss possible with DehydraTECH-CBD. Those same four formulation groups (A, B, C, and D) all achieved superior blood sugar control performance than the Placebo Group at the 8th and 12th week, and mostly superior blood sugar control performance to SOC Group at the 4th and 8th week periods. The SOC Group achieved its best blood sugar control in the final four weeks of the study.
Animal Weights (grams)
Study Groups | End of | Day | % Change | Day | % Change | Day | % Change |
A: DHT-CBD1 | 427.9 | 432.6 | +1.10% | 438.0 | +2.36% | 432.3 | +1.05% |
B: DHT-CBD2 | 394.6 | 393.3 | -0.33% | 386.1 | -2.15% | 374.9 | -5.00% |
C: DHT-CBD3 | 416.0 | 408.8 | -1.72% | 407.3 | -2.08% | 402.5 | -3.24% |
D: DHT-CBD4 | 431.2 | 431.7 | +0.11% | 434.2 | +0.69% | 419.0 | -2.83% |
E: DHT-Rybelsus1 | 394.9 | 394.6 | -0.06% | 401.4 | +1.65% | 393.6 | -0.32% |
F: DHT-Rybelsus2 | 406.2 | 409.1 | +0.70% | 406.7 | +0.11% | 403.1 | -0.78% |
G: DHT-Semaglutide | 394.2 | 394.8 | +0.15% | 399.0 | +1.21% | 394.1 | -0.02% |
H: DHT-Liraglutide | 392.2 | 385.7 | -1.65% | 373.6 | -4.74% | 369.1 | -5.88% |
I: DHT-Combo | 440.8 | 453.3 | +2.84% | 448.6 | +1.77% | 444.1 | +0.75% |
J: DHT-Combo | 446.7 | 468.7 | +4.93% | 463.4 | +3.74% | 451.4 | +1.05% |
K: Vehicle Control | 427.7 | 442.5 | +3.46% | 440.1 | +2.90% | 433.7 | +1.40% |
L: Rybelsus Control | 430.2 | 446.7 | +3.84% | 459.2 | +6.74% | 454.5 | +5.65% |
Notes
- Groups A through D were different DehydraTECH-CBD compositions
- Groups E and F were reformulated Rybelsus DehydraTECH compositions
- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions
- Recalculations led to slight changes from earlier reported data
- Group K received only water as a placebo control versus the other groups that received water+drug at dosing
- Group L received unadulterated Rybelsus® with no DehydraTECH processing
Both of the combination drug groups (I and J) achieved superior body-weight control performance to both the Placebo Group and SOC Group at the 12th week, but inferior blood sugar control across most time points.
Blood Sugar Levels (mmol/L)
Study Groups | End of Acclimation Period | Day | % Change | Day | % Change | Day | % Change |
A: DHT-CBD1 | 27.4 | 26.2 | -4.31% | 26.9 | -1.90% | 27.7 | 1.09% |
B: DHT-CBD2 | 28.4 | 29.2 | 2.73% | 26.6 | -6.22% | 27.3 | -3.76% |
C: DHT-CBD3 | 26.4 | 24.9 | -5.99% | 27.1 | 2.46% | 27.5 | 3.85% |
D: DHT-CBD4 | 24.6 | 27.9 | 13.16% | 26.8 | 8.94% | 27.0 | 9.75% |
E: DHT-Rybelsus1 | 26.4 | 25.5 | -3.60% | 26.8 | 1.33% | 26.8 | 1.59% |
F: DHT-Rybelsus2 | 24.9 | 26.8 | 7.70% | 26.4 | 5.96% | 27.3 | 9.58% |
G: DHT-Semaglutide | 26.3 | 25.9 | -1.52% | 27.8 | 5.54% | 26.9 | 2.13% |
H: DHT-Liraglutide | 26.4 | 25.8 | -2.08% | 25.2 | -4.56% | 23.3 | -11.54% |
I: DHT-Combo | 25.1 | 27.2 | 8.37% | 28.2 | 12.35% | 26.8 | 6.77% |
J: DHT-Combo | 23.5 | 27.0 | 14.89% | 27.0 | 14.89% | 26.4 | 12.34% |
K: Vehicle Control (Placebo) | 24.2 | 25.7 | 6.2% | 27.7 | 14.46% | 26.7 | 10.33% |
L: Rybelsus Control | 24.3 | 25.1 | 3.29% | 26.1 | 7.41% | 24.2 | -0.41% |
The two groups of the Study (I and J), that combined doses of either DehydraTECH-semaglutide or DehydraTECH-liraglutide with DehydraTECH-CBD were generally worse performers than either of the drugs alone with respect to blood sugar control, although, regarding reduced body-weight control, they were nonetheless generally superior to both the Placebo Group and the SOC Group.
"Overall, the findings from our animal study showed benefits of DehydraTECH-processing with all drugs studied alone or in combination relative to the Rybelsus® control formulation," said John Docherty, President & CSO of Lexaria Bioscience Corp. "This Study is strongly supportive of our plans to advance to our upcoming Phase 1b chronic dosing clinical study in Australia through our Australian subsidiary, Lexaria (AU) Pty Ltd, which we have endeavoured to design to allow for maximum impacts upon blood glucose and body weight control while also evaluating safety and tolerability in humans."
All body weight and blood glucose findings from the Study, including from the SOC Group and Placebo Group, have now been received. Additional data processing and interpretation remains, including the analyses of brain and blood absorption pharmacokinetic results and more. Lexaria has not yet received this data from the third-party lab and will report upon same when results are available.
About the Study
The Study model selected - diabetic Zucker rates with unlimited food and water provided 24 hours per day - is a more stringent model design than that used in most studies primarily focused on weight loss. As such, it is expected that weight loss results within this Study would be less than other third-party weight loss studies and that weight gain would not be unexpected. The primary rational for conducting this Study was to perform a relative comparison of many different formulations and test for relative differences between them in a diabetic state purposefully perpetuated for the duration of the Study. Future animal work that is primarily focused on weight loss - already under design by Lexaria - will use a study model more typical of weight loss studies that do not provide 24-hour unlimited food and water.
Study WEIGHT-A24-1 was completed using diabetic, pre-conditioned Zucker rats. Each group of the Study was dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples were collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study group, statistical significance was not necessarily expected - though achieved in some instances - and commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Brain tissue is also in the process of being analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH groups, as Lexaria has evidenced numerous times in previous animal studies. The Study also included a comprehensive battery of liver and kidney function testing and blood chemistry analyses that remain to be analysed and reported. LC-MS/MS and other techniques were used to analyse samples.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
World's First-Ever Study Tracking Biodistribution of DehydraTECH GLP-1 Molecules
KELOWNA, BRITISH COLUMBIA / November 14, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has engaged a contract research organization to perform the world's first-ever fluorescently tagged DehydraTECH-semaglutide ("FTS") rodent biodistribution study (the "Study").
Distribution of a drug once it enters the body can provide vital clues as to the understanding of that drug's ability to bind with targeted receptor cells, avoid concentration at physical sites that might be prone to fostering adverse side effects, and increase the drug's ultimate efficacy. Lexaria hopes to discover whether the DehydraTECH processing of semaglutide improves its biodistribution in any significant way compared to conventional orally administered semaglutide formulation practices.
The FTS will be tracked via fluorescent imaging detection to evidence how and where the semaglutide distributes and localizes following oral ingestion in Sprague-Dawley rats. Later in the Study, the animals will be euthanized and various key tissues will be examined including the brain, pancreas, lung, kidney, liver and heart for more detailed fluorescent imaging detection showing very specific tissue localization patterns and concentrations.
Lexaria has already begun the early-stage collaboration with the third-party laboratory that will synthesize the FTS that will then be used to create the DehydraTECH-semaglutide test articles. There will be two different test articles manufactured and tested:
FTS will be combined with ingredients in the proportions used within the Rybelsus® orally-administered product sold today designed to mimic Rybelsus® performance, without DehydraTECH processing.
FTS will be combined with patented DehydraTECH ingredients and processes to evidence potential biodistribution differences when DehydraTECH is used compared to the Rybelsus®-mimicking control FTS formulation.
The Study will also include use of certain glucagon-like peptide-1 ("GLP-1") receptor specific antibodies detectable through an immunofluorescence methodology to allow the analytical laboratory to confirm the extent of GLP-1 receptor binding of the two FTS formulations in the tissue samples taken from the animals, providing an additional detailed measure of the FTS distribution and localization patterns.
Results from the Study will enhance any future communications between Lexaria and prospective industry partners. Study work has already begun with completion and final reporting expected in May, 2025.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
DehydraTECH clinical test article manufacturing has been completed
KELOWNA, BC / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study").
The Company is also announcing that clinical test article manufacturing for all planned Study arms has already been completed. This includes production for the four planned DehydraTECH formulation Study arms and clinical repackaging of the commercially available Rybelsus® comparator tablets for the Study control arm as follows:
Arm 1 - DehydraTECH-CBD capsules
Arm 2 - DehydraTECH-semaglutide capsules
Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules
Arm 4 - Rybelsus® tablets (positive control)
Arm 5 - DehydraTECH-tirzepatide capsules (optional arm with offset start date)
It is possible that the First Patient, First Dose ("FPFD") Study milestone could be achieved in late December, and failing that, in January, 2025.
"We are delighted by the work of our project team in completing study documentation preparation and primary ethics board submission so quickly and efficiently," said John Docherty, President of Lexaria Bioscience Corp. "Their nearly round-the-clock work has resulted in a rapid ethics board approval so that the study can start dosing as soon as possible. Together with our expedited manufacturing processes recently completed, we have potentially saved months of time."
The Study is planned to be conducted using seven clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. HREC approval has been received for the primary clinical site, while clinical trial notification acknowledgement by the Australian Therapeutic Goods Administration and HREC approvals for the remaining clinical sites remain to be completed; but expected shortly now that primary site HREC approval is in hand. Quality control release testing of the clinical test articles also remains to be completed. The Study, upon completion, is expected to be equally regarded as a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").
About The Study
The Study is planned to commence with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study arms 1-4, with the DehydraTECH-tirzepatide Study arm 5 to be added at a later date if supported by positive results from Lexaria's separate ongoing study GLP-1-H24-3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study.
Arms 2 and 3 of the Study will use DehydraTECH-processed pure semaglutide and will be compared to Study Arm 4 which will use Rybelsus® tablets (semaglutide) that contains Novo Nordisk's proprietary salcoprozate sodium ("SNAC") technology. It is a world-first that pure semaglutide processed with DehydraTECH technology without SNAC will be compared directly to SNAC-enabled Rybelsus® in a multiple week human study.
Arm 1 of the Study will utilize a proprietary, patented DehydraTECH-CBD formulation. Our 2022 diabetes animal study DIAB-A22-1, utilizing DehydraTECH-CBD evidenced weight loss of 7% and reduced blood glucose levels of 19.9%+/-7% (p<0.05) during a multi-week rodent study without the addition of any GLP-1 drugs. Lexaria is looking forward to discovering whether DehydraTECH-CBD studied alone, or together with DehydraTECH-GLP-1, in humans might offer some benefit of improved weight loss and/or reduced side effects as compared to Rybelsus® alone.
In its first-ever GLP-1 study in humans reported in January, 2024, Lexaria discovered that DehydraTECH processing of Rybelsus®-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus® itself. Also, in rodent study work Lexaria has undertaken with updates reported in October, 2024, Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus® formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide as have been shown to be integral to SNAC-enabled semaglutide gut absorption.
Lexaria has several important objectives for this Study:
Is DehydraTECH processed CBD and/or semaglutide safe over the Study duration in the Study population?
Does DehydraTECH-(pure)semaglutide outperform Rybelsus®-semaglutide with its proprietary SNAC technology in measures of blood sugar control or weight loss?
Does DehydraTECH processing enhance real world outcomes such as weight loss and blood sugar control over the Study duration?
Does DehydraTECH processing of pure semaglutide evidence reduced side effects during daily dosing for 12 weeks, as DehydraTECH processing of Rybelsus® seemed to achieve in a prior human study utilizing one single daily dose?
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
DehydraTECH™ for GLP-1 being optimized for global pharmaceutical use
KELOWNA, BC / November 7, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms provides the following glucagon-like peptide-1 ("GLP-1") industry update.
It is no surprise that Novo Nordisk's ("Novo") blockbuster drug, semaglutide, which is sold under the brand names Ozempic®, Wegovy®, and Rybelsus®, is the bestselling diabetes and weight loss drug in the world today. Novo has, for one hundred years, been the world's leading diabetes drug and research company, after receiving the extraction and purification techniques from the Canadian doctor who discovered insulin in 1921. They owned six of the world's top-15 bestselling diabetes drugs, for combined sales in 2022 of US$16.87 billion for diabetes applications alone, and in just the first half of 2024 generated $8.3 billion from sales of the blockbuster drug, Ozempic®.
Lexaria's strategy is to continue developing and optimizing our wholly-owned DehydraTECH™ drug delivery platform for application in the GLP-1 space, positioning it as a "must-have" technology for larger companies seeking to develop, defend or increase their cash flows from existing drugs as well as to be utilized in early stages of drug development for next-gen GLP-1 drugs due to hit the market in 2026, 2027, and beyond.
An 'arm's race' of sorts has begun amongst the world's pharmaceutical companies once it became apparent that the GLP-1 drugs responsible for life-changing outcomes in diabetes management were also responsible for impressive weight-loss benefits. Close behind Novo is Eli Lilly with its own drug, tirzepatide, which is branded as both Mounjaro® and Zepbound®. Because of its dual action properties, working on both GLP-1 receptors and also glucose-dependant insulinotropic polypeptide pathways ("GIP"), tirzepatide is even more effective at weight loss and is expected by some analysts to reach $50 billion in global total annual revenue.
Global pharmaceutical companies are competing against each other in the GLP-1 space utilizing three main strategies:
Developing or acquiring their own new GLP-1 and related molecules under traditional drug development techniques;
Developing or acquiring technologies and intellectual property ("IP") that improves the delivery pharmacokinetics of GLP-1 in attempts to increase drug absorption and decrease drug side effects; and,
Developing or acquiring related technologies and IP that can act as platforms for improved drug performance and patient outcomes.
On November 4, 2024, Ascendis Pharma announced it had granted an exclusive worldwide license to its technology platform to Novo for Novo products in metabolic disease - obesity and type 2 diabetes. In return, Ascendis will be eligible to receive total payments of US$285 million from Novo for this initial program, as well as payments up to an additional $77.5 million for each additional disease product candidate.
On September 18, 2024, it was reported that Novo was agreeing to pay NanoVation Therapeutics up to $600 million, plus research funding in addition to tiered royalties to collaborate on up to seven programs for technology utilizing NanoVation's lipid nanoparticle technology.
On September 16, 2024, Korro Bio announced a collaboration wherein it could receive up to $530 million in aggregate payments from Novo to apply Korro's patented platform to develop RNA editing product candidates focused initially on cardiometabolic diseases.
In September 2024, Eli Lilly began working with Haya Therapeutics by way of up to a $1 billion investment, to use a proprietary RNA-guided genome platform to target obesity and other metabolic conditions.
In August, 2024, Canadian-based Inversago Pharma announced its pending acquisition by Novo for up to $1.08 billion if certain milestones are achieved. Inversago has its own weight loss drug, INV-202, that showed weight loss of 3.3% in a small human study of 37 people.
In February, 2024 Viking Therapeutics announced positive Phase II weight-loss results from its GLP-1/GIP drug and watched its company valuation sore from less than $2 billion to more than $8 billion as a result. Viking is considered by some to be a leading takeover candidate for more-established pharmaceutical companies looking to stake their ground in the GLP-1 sector.
In February, Novo paid $16.5 billion to acquire its contract manufacturer Catalent, and their three manufacturing plants working diligently to churn out Ozempic® and Wegovy®, vertically integrating the semaglutide franchise.
In December, 2023, Eli Lilly agreed to pay up to $494 million to Fauna Partnership, to utilize its artificial intelligence platform to search for new molecules focused on weight loss.
The GLP-1 and related drug sector has generated tens of billions of dollars in corporate M&A and licensing activity even as it is on its way to becoming one of the largest drug sectors in history with estimates widely ranging from $100 billion per year to as much as $471 billion per year in revenue.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing blood sugar groups
KELOWNA, BC / October 24, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) blood sugar results from the recently completed animal study WEIGHT-A24-1 (the "Study").
Blood Sugar Levels (mmol/L) | |||||||
DehydraTECH | Day 7 | Day | % | Day 56 | % | Day 84 | % |
A: CBD1 | 27.4 | 26.2 | -4.31% | 26.9 | -1.90% | 27.7 | 1.09% |
B: CBD2 | 28.4 | 29.2 | 2.73% | 26.6 | -6.22% | 27.3 | -3.76% |
C: CBD3 | 26.4 | 24.9 | -5.99% | 27.1 | 2.46% | 27.5 | 3.85% |
D: CBD4 | 24.6 | 27.9 | 13.16% | 26.8 | 8.94% | 27.0 | 9.75% |
E: Rybelsus1 | 26.4 | 25.5 | -3.60% | 26.8 | 1.33% | 26.8 | 1.59% |
w/SNAC | |||||||
F: Rybelsus2 | 24.9 | 26.8 | 7.70% | 26.4 | 5.96% | 27.3 | 9.58% |
w/SNAC | |||||||
G: Semaglutide | 26.3 | 25.9 | -1.52% | 27.8 | 5.54% | 26.9 | 2.13% |
No SNAC | |||||||
H: Liraglutide | 26.4 | 25.8 | -2.08% | 25.2 | -4.56% | 23.3 | -11.54% |
No SNAC |
Notes
- Groups A through D were different DehydraTECH-CBD compositions
- Groups E and F were reformulated Rybelsus DehydraTECH compositions
- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions
- Recalculations led to slight changes from earlier reported data
Lexaria is strongly encouraged that the DehydraTECH-liraglutide and DehydraTECH-CBD groups A and B outperformed all three of the Rybelsus® and pure semaglutide DehydraTECH composition groups regardless of whether the semaglutide had or had not been processed with the salcaprozate sodium technology known as "SNAC". Rybelsus®, which utilizes Novo Nordisk's proprietary SNAC technology, is the world's only orally administered GLP-1 drug brand.
Study data for four additional animal groups (I, J, K, and L), including a positive control group of Rybelsus® that has not been processed with DehydraTECH, will be available soon. Of the eight Study groups reported on today, DehydraTECH-CBD group B and the sole DehydraTECH-liraglutide group H were both successful in reducing blood sugar levels, while the other six groups, including all three of the Rybelsus® and pure semaglutide DehydraTECH composition groups, were not.
This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. Thus, the outperformance of DehydraTECH-liraglutide compared to the other groups is of notable interest and was unexpected. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.
Usually, injected versions of drugs have greater efficacy than orally administered versions of the same drug because of superior pharmacokinetics ("PK"). Lexaria's DehydraTECH drug delivery technology has historically enhanced the PK of orally administered drugs, opening a potential for viability in commercial markets.
Additional data from this Study is pending, including body weight and blood glucose findings from the second Study cohort that included positive and vehicle (placebo) control arms. Analyses of brain and blood absorption pharmacokinetic results is also underway, although unforeseen delays at the third-party laboratories involved is affecting timing of completion of this work. Lexaria is working with these laboratories to minimize further delays and will report on these data as soon as possible.
About the Study
Study WEIGHT-A24-1 was completed using diabetic, pre-conditioned Zucker rats. Each arm of the Study was dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples were collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups were offered unlimited access to food throughout the course of the Study.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing weight loss groups
Accelerated rates of weight loss were experienced during the final 4 weeks of the study in all DehydraTECH groups
KELOWNA, BC / October 22, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) body weight results from the recently completed animal study WEIGHT-A24-1 (the "Study").
Animal Weights (grams)
DehydraTECH | End of | Day | % | Day | % | Day | % |
A: CBD1 | 427.9 | 432.6 | +1.10% | 438.0 | +2.36% | 432.3 | +1.046% |
B: CBD2 | 394.6 | 393.3 | -0.33% | 386.1 | -2.15% | 374.9 | -4.996% |
C: CBD3 | 416.0 | 408.8 | -1.72% | 407.3 | -2.08% | 402.5 | -3.237% |
D: CBD4 | 431.2 | 431.7 | +0.11% | 434.2 | +0.69% | 419.0 | -2.829% |
E: Rybelsus1 | 394.9 | 394.6 | -0.06% | 401.4 | +1.65% | 393.6 | -0.321% |
F: Rybelsus2 | 406.2 | 409.1 | +0.70% | 406.7 | +0.11% | 403.1 | -0.780% |
G: Semaglutide | 394.2 | 394.8 | +0.15% | 399.0 | +1.21% | 394.1 | -0.017% |
H: Liraglutide | 392.2 | 385.7 | -1.65% | 373.6 | -4.74% | 369.1 | -5.880% |
Average | 407.1 | 406.3 | -0.21% | 405.8 | -0.37% | 398.6 | -2.127% |
Notes
Groups A through D were different DehydraTECH-CBD compositions
Groups E and F were reformulated Rybelsus® DehydraTECH compositions
Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions
Recalculations led to slight changes from earlier reported data
Lexaria is strongly encouraged that the DehydraTECH-liraglutide and select DehydraTECH-CBD groups B, C, and D outperformed all three of the Rybelsus® and semaglutide DehydraTECH composition groups regardless of whether the semaglutide had or had not been processed with the salcaprozate sodium technology known as "SNAC". Rybelsus®, which utilizes Novo Nordisk's proprietary SNAC technology, is the world's only orally administered GLP-1 drug brand.
This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. In humans, semaglutide has been shown in other studies to be more than twice as effective at promoting weight loss as liraglutide . Thus, the outperformance of DehydraTECH-liraglutide compared to DehydraTECH-semaglutide is of notable interest. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.
Teva Pharmaceuticals (NYSE:TEVA) on June 24, 2024, announced the authorized launch of a generic version of Novo Nordisk's Victoza® as injected liraglutide and noted that Victoza had annual sales of $1.656 billion as of April, 2024.
Lexaria notes that it has already filed patent applications to recognize the unique outperformance of liraglutide once processed with DehydraTECH delivery technology.
Readers are cautioned to not compare results of this animal study to human weight loss studies , primarily because unlimited food and water has been provided to the animals for the entire duration of this Study. Offered unlimited food, many rats will reach morbid obesity.
The primary value in this Study is the relative performance of the different Study groups, which has provided directional evidence for additional future work. For context, in an older Lexaria diabetic animal study DIAB-A22-1 reported on March 2, 2023 , the obese control group of animals that received no drug treatment , experienced 3.04% weight gain during the first 28 days of that study.
During the initial acclimation phase of 34 days before the beginning of dosing in this Study, the animals gained 10.9% body weight on average. Actual weight decreases or slower rates of weight gain have since been achieved in the 12 weeks of dosing in all Study groups receiving DehydraTECH drug therapies. Importantly, accelerated rates of weight loss were experienced in all DehydraTECH groups during the final 4 weeks of the study.
Additional data from this Study is pending including blood glucose findings from the animals reported herein, as well as body weight and blood glucose findings from the second study cohort that included positive and vehicle (placebo) control arms. Analyses of brain and blood absorption pharmacokinetic results is also underway, although unforeseen delays at the third-party laboratories involved is affecting timing of completion of this work. Lexaria is working with these laboratories to minimize further delays and will report on these data as soon as possible.
About the Study
Study WEIGHT-A24-1 was completed using diabetic, pre-conditioned Zucker rats. Each arm of the Study was dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples were collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups are offered unlimited access to food throughout the course of the Study.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
KELOWNA, BC / October 16, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX; LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced that it has closed its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 1,633,987 shares of common stock at a purchase price of $3.06 per share. In a concurrent private placement, the Company issued unregistered warrants to purchase up to 4,551,019 shares of common stock at an exercise price of $3.06 per share. The warrants will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants (the "Stockholder Approval Date") and will expire five years from the Stockholder Approval Date.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
The gross proceeds to the Company from the offering were approximately $5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.
The shares of common stock (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-262402) that was declared effective by the Securities and Exchange Commission (the "SEC") on February 4, 2022. The offering of the shares of common stock in the registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].
The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
In addition, effective on the closing of the offering certain outstanding warrants to purchase 2,917,032 shares of the Company's common stock issued in April 2024 will be cancelled.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, the intended use of proceeds from the offering, receipt of Stockholder Approval and the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, market and other conditions, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com