Monthly Archives: March 2024

KELOWNA, BC / March 14, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the appointment of Nelson Cabatuan, CPA, as Chief Financial Officer (CFO) effective immediately. As a member of the executive leadership team, Mr. Cabatuan will lead the Company's financial operations.

"Nelson's deep financial leadership experience will be instrumental to the execution of Lexaria's long-term growth strategy as we continue to maximize the potential use of our DehydraTECH platform for GLP-1 and other therapeutic applications with high unmet medical needs," said Chris Bunka, Chief Executive Officer of Lexaria. "On behalf of the entire Lexaria team, I'm thrilled to welcome Nelson as our CFO."

Mr. Cabatuan has over 15 years of corporate finance and operations experience within the life sciences industry, most recently serving as SVP Finance and Operations at Rain Oncology, Inc., a late-stage precision oncology biotech company. At Rain, Mr. Cabatuan built and led the company's financial organization that experienced significant growth during his tenure. Previously, Mr. Cabatuan served in various roles at Rigel Pharmaceuticals, Inc., including as Vice President Finance. At Rigel, he was a key member of the executive team that developed and launched TAVALISSE® for the treatment of chronic immune thrombocytopenia.

"Lexaria has a significant opportunity in continuing its pursuit as a global innovator in drug delivery platforms as proven by the strong potential of DehydraTECH in GLP-1 and hypertension," said Mr. Cabatuan. "I'm excited to join the team and look forward to contributing to the Company's progress in GLP-1 and other areas."

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 39 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

  • First-ever dissolvable DehydraTECH-GLP-1 oral dose formulation to be tested
  • Rybelsus® semaglutide will act as the positive control

KELOWNA, BC / March 7, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces it has hired a contract research organization ("CRO") to perform the Company's second DehydraTECH-powered glucagon-like peptide 1 ("GLP-1") human pilot study #2 (the "Study").

The Study will be a randomized, crossover, placebo-controlled investigation that will compare three dose formulations each at a 7 mg semaglutide dose:

  • a positive control Rybelsus® swallowed tablet;
  • DehydraTECH-semaglutide swallowed capsules; and,
  • for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.

Semaglutide swallowed into the stomach/intestine absorbs into the bloodstream at an exceptionally low rate typically at less than 1%, when it does not use any absorption technology because, in part, the acidic environment of the stomach is known to seriously degrade GLP-1 drugs.

"DehydraTECH has previously shown an ability to improve delivery of certain drugs destined for the bloodstream, through the buccal/sublingual tissues of the mouth and throat," said Chris Bunka, CEO of Lexaria Bioscience Corp. "If this new Study is successful in demonstrating efficacy and safety, the potential for a new era in GLP-1 delivery without the need for painful injections or stomach-upsetting tablets, could be within reach."

Manufacturing of the test articles for this Study is anticipated to be completed within 30 days. Independent Review Board approval is required before the Study can commence, and the Company will provide our next update when dosing has begun.

CORRECTION

In Lexaria's press release of March 4, we described an upcoming animal study as having an 8-week duration. That was a typographical error: the correct animal study duration is 12-weeks.

About the Study

Many design characteristics of the Study will be fundamentally the same as in Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles will be compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, and blood glucose levels. Blood samples will be taken multiple times during the first 10 hours post dosing; a final blood draw will be taken 24 hours after dosing; and, a standardized meal will be fed to the test subjects at a point in time after dosing. Eight healthy subjects are expected to be dosed with each test article following a cross over study design across three study visits.

About Semaglutide

Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.

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 39 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

  • Multiple DehydraTECH-GLP-1 and DehydraTECH-CBD formulations to be tested
  • Chronic dosing over a 12-week treatment period
  • Will assess weight loss and blood glucose level control
  • Efficacy through possible brain absorption delivery enhancement to be assessed

KELOWNA, BC / March 5, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces details of an 8-week animal study WEIGHT-A24-1 (the "Study") to examine diabetes and weight loss effects of DehydraTECH-processed glucagon-like peptide 1 ("GLP-1") drugs and DehydraTECH-processed cannabidiol, alone and in combination.

The contract for the Study has been awarded to a third-party, Health Canada-licensed Canadian research laboratory. Manufacturing of the compositions for the first 8 of the 12 arms of the Study has already been completed, and those arms will commence as soon as the testing laboratory is able to do so, expected to begin within 45 days.

Detailed information of the 12 Study arms is as noted:

  • Group 1: DehydraTECH-CBD (composition "A")
  • Group 2: DehydraTECH-CBD (composition "B")
  • Group 3: DehydraTECH-CBD (composition "C")
  • Group 4: DehydraTECH-CBD (composition "D")
  • Group 5: DehydraTECH-GLP-1 (re-formulated Rybelsus® "E")
  • Group 6: DehydraTECH-GLP-1 (re-formulated Rybelsus® "F")
  • Group 7: DehydraTECH-GLP-1 (pure semaglutide "G")
  • Group 8: DehydraTECH-GLP-1 (pure liraglutide "H")
  • Group 9: Combination of one of E, F, or G and one of A, B, C, or D (TBD)
  • Group 10: Combination of H and one of A, B, C, or D (TBD)
  • Group 11: Vehicle (placebo) arm
  • Group 12: Positive control arm

Each arm of the Study will be dosed for an 8-week period following an acclimation period. During the Study, over 1,500 blood plasma samples will be collected from the total rat population of 72 animals for purposes of detailed pharmacokinetic drug delivery analyses. Body weight and blood glucose readings will be taken prior to Study start and 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. LC-MS/MS and other techniques will be used to analyse samples. Also, the Study will allow examination of DehydraTECH-processed semaglutide with and without the salcaprozate sodium "SNAC" technology currently found within Rybelsus® tablets. We will be collecting and reporting interim results prior to the end of the Study.

Study arms 9 and 10 will have a later start-date due to some information outputs required from the other Study arms before they and study arms 11 and 12 can commence. The Company will provide an update when animal dosing has begun.

In previous animal research with two other molecules, including cannabidiol, Lexaria demonstrated through brain tissue examination that DehydraTECH processing can enable higher levels of drug delivery across the blood-brain-barrier and directly into brain tissue. It is unknown, today, whether DehydraTECH processing can deliver higher quantities of GLP-1 drugs into brain tissue, and Study WEIGHT-A24-1 is designed to answer that question in animals.

Recent research has indicated "that a small peptide GLP-1R agonist penetrates the brain and activates a subset of GLP-1R-expressing neurons in the arcuate nucleus to produce weight loss." Lexaria believes that, if it can evidence that DehydraTECH processing of GLP-1 drugs can enable greater penetration into brain tissue, then this may help to explain how the GLP-1 drug(s) powered by DehydraTECH may be more effective at enhancing beneficial outcomes such as weight loss and blood sugar control. In turn, this could also potentially allow for lower dosing and a concomitant reduction in adverse side effects.

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 39 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 / March 4, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, informs that its wholly-owned and patented DehydraTECH-CBD formulation, when administered to rodents in an 8-week study (DIAB-A22-1), resulted in weight loss of 7% and a reduction of 19.9% (p<0.05) in blood glucose. Lexaria has now signed contracts to begin animal study WEIGHT-A24-1; (the "Study"), which will be a large, multi-week animal study that will substantially progress its further DehydraTECH-GLP-1 and DehydraTECH-CBD weight loss investigations.

Lexaria also recently published results in a human study, wherein a single 7 mg semaglutide dose from Rybelsus® processed with DehydraTECH and administered to humans, was absorbed at a significantly higher level than without DehydraTECH processing; and also managed blood glucose levels more effectively without any blood glucose spiking after eating.

Together, these discoveries strongly support additional investigations, including:

  • determining whether daily dosing of DehydraTECH-GLP-1 might result in sustained higher concentrations of GLP-1 in blood over an extended treatment duration than without DehydraTECH processing; and whether such a higher blood concentration might result in greater weight loss over time, and
  • determining whether DehydraTECH-CBD, specially formulated for diabetes control and weight loss, alone and/or in conjunction with DehydraTECH-GLP-1, might also result in greater weight loss and/or blood glucose control over time.

Manufacturing of the test articles for 8 of the 12 arms of the new animal Study has already been completed, and dosing in those arms will commence as soon as the third-party laboratory is able to do so, expected to begin within 45 days. Four different DehydraTECH-CBD compositions will be tested, as well as 4 different DehydraTECH-GLP-1 compositions (comprised of 3 different DehydraTECH-semaglatide formulas and a single, first ever DehydraTECH-liraglutide composition). The comprehensive Study will also test 1 DehydraTECH-CBD composition combined with DehydraTECH-semaglutide; and 1 DehydraTECH-CBD composition combined with the DehydraTECH-liraglutide composition.

More detailed Study information will be released soon about study WEIGHT-A24-1 in separate news.

THE MARKET OPPORTUNITY

Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk.

GLP-1 drugs have recently been approved by the FDA for type two diabetes and weight loss management. Weight loss of between 10 pounds to 33 pounds, or more, has been widely reported. One 68-week study of 667 people reported an average loss of 15% of body weight.

Because GLP-1 drugs have experienced FDA approvals as recently as 2021 and 2022, and because the health benefits of this drug class are still being discovered and understood, the potential market size is unknown. Published reports are widely estimating $100 billion in sales per year, by 2030. At least one analyst from Guggenheim Partners published a note on September 12, 2023 in which he explained how "the total addressable market for these so-called incretin drugs could balloon to $150 billion to $200 billion."

Diabetes is a disease whereby the body does not produce sufficient insulin, leading to higher than normal levels of sugars in the blood. Risks of kidney disease, vision loss, heart and cardiovascular disease and more are greatly enhanced by individuals with diabetes. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world.

People with type-2 diabetes can often control the disease through lifestyle changes and/or taking certain diabetes medications, whereas those with type-1 diabetes are required to add insulin to their body through syringes, insulin pumps, or other similar devices. Thus, the treatment of diabetes includes devices, drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in 2021. The global diabetes drug market is estimated at $63.1 billion in 2021. Due to the pain and unpleasantness of injections, many diabetes sufferers prefer to treat their condition with drugs rather than devices, if they have the choice. More than 1.9 billion people were overweight in 2016, and due to the growth in obesity, which has nearly tripled from 1975 to 2016, the number of people experiencing diabetes continues to grow.

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 39 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 / March 1, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that the U.S. Food and Drug Administration ("FDA") has confirmed effectiveness as of February 28, 2024 of the Company's investigational new drug ("IND") application thereby cleared for Lexaria to conduct its planned U.S. Phase 1b hypertension clinical trial HYPER-H23-1 utilizing DehydraTECH-CBD.

"This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA's high level of regulatory scrutiny sufficient to formally commence U.S. registrational clinical testing towards possible future pharmaceutical commercialization," said John Docherty, president of Lexaria. "We look forward to commencing this important clinical trial and building upon the wealth of early-stage clinical data we have gathered and presented to the FDA to-date demonstrating the safety, efficacy and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients."

Lexaria is pleased to have complied with the FDA's rules and procedures for clearance to perform this important registrational trial. The Company will further announce when it is ready to begin the study, subject to certain conditions including raising sufficient funding.

Background and Medical/Market Rationale

From 2018 through 2022, Lexaria has previously conducted five human clinical studies of DehydraTECH-CBD in an aggregate total of 134 healthy normal and hypertensive volunteers, without recording a single serious adverse event (the "Studies"). The Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.

Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations.

Findings from Lexaria's study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in the peer-reviewed and published journal, "Biomedicine and Pharmacotherapy". This is significant because the FDA has previously communicated clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action.

About Planned Clinical Trial HYPER-H23-1

Clinical trial HYPER-H23-1 is entitled 'A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension'. The primary objective of the trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.

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 39 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, 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, 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