KELOWNA, BC / September 3, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has entered into a Material Transfer Agreement with a pharmaceutical company ("PharmaCO") to evaluate Lexaria's DehydraTECHTM technology in a pre-clinical setting.

Under the terms of the agreement, Lexaria is responsible for formulation and supply of certain DehydraTECH compositions. The pharmacokinetics of DehydraTECH compositions will be evaluated in animal studies. Lexaria has awarded to PharmaCO a temporary exclusive license option limited to specific DehydraTECH concepts and formulations under examination. The work should be complete within roughly 6 months or less.

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

  • Absorption improvements appear to continue with DehydraTECH-processed Rybelsus® vs. Rybelsus® tablets even under "fed" conditions

  • DehydraTECH-treated Rybelsus® does absorb through a mouth-melt product format

KELOWNA, BC / August 29, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that tolerability and additional pharmacokinetic ("PK") results from human pilot study #2, GLP-1-H24-2, (the "Study") have been received. Lexaria's DehydraTECH-processed Rybelsus® capsules demonstrated superior tolerability in delivering the GLP-1 drug semaglutide versus commercially available Rybelsus®.

We were pleased to find that none (0) of the 9 people taking the DehydraTECH-processed Rybelsus® swallowed as a capsule experienced any adverse events whatsoever. However, of the 9 human volunteers in the Study taking the Rybelsus® tablet, 6 of them experienced mild adverse events. Five of those same 6 people experienced mild adverse events from taking the dissolvable oral mouth-melt format of DehydraTECH-processed Rybelsus®.

These tolerability findings nicely build upon the those from Lexaria's previous human pilot study #1, GLP-1-H24-1, which also showed the DehydraTECH-processed Rybelsus® capsules to be generally better tolerated than the Rybelsus® tablets that demonstrated instances of moderate nausea or diarrhea.

Adverse Events from Pilot Studies #1 (GLP-1-H24-1) and #2 (GLP-H24-2)

Pilot Study #1
(n=7)

Pilot Study #2
(n=9)

Total (n=16)

Rybelsus® Tablet

4 mild
3 moderate

6 mild
0 moderate

10 mild (63%)
3 moderate (19%)

DehydraTECH-processed Rybelsus Capsule

7 mild
0 moderate

0 mild
0 moderate

7 mild (44%)
0 moderate (0%)

Combined with the 7 people involved in Lexaria's first human pilot study examining DehydraTECH processing of semaglutide capsules, a total of 16 people have now been dosed with comparable DehydraTECH-processed semaglutide capsules and Rybelsus® tablets. Of those 16 people, 13 or 81%, experienced mild or moderate side effects with the Rybelsus® tablet and only 7 people, or 44%, experienced only mild side effects with the Rybelsus® that was processed with DehydraTECH and administered via capsules. Most of the side effects experienced in all cases were of a gastrointestinal nature including belching, diarrhea and nausea that are commonly associated with GLP-1 drugs, although intensity was lower in all instances with the DehydraTECH-processed Rybelsus® capsules in pilot study #1 or absent altogether in the present Study.

The continuing evidence of decreased adverse events with the DehydraTECH-processed Rybelsus® capsules compared to commercially available Rybelsus® tablets is encouraging. Other reports have noted that Rybelsus® generally produces slightly higher incidences of several common side effects as compared to the injectable product Ozempic®, which outsells Rybelsus® by a factor of almost five-fold. DehydraTECH's ability to improve oral tolerability could, in future, however, help to drive increased use of oral GLP-1 product formats, if proven definitively through thorough registered clinical testing.

Lexaria also reports that the third arm of the Study that evaluated a DehydraTECH-processed Rybelsus® formulation as an in-mouth dissolvable tablet also showed some promise from a conceptual perspective. Across the 18 blood draws from the 20-minute mark until the 24-hour mark in the Study, the average blood concentration level (nmol/) of the Rybelsus® tablet was 3.93; for the DehydraTECH-processed Rybelsus® mouth-melt it was 1.27 or 32.3% of the Rybelsus® tablet results; and for the DehydraTECH-processed Rybelsus® it was 4.20 or 106.9% of the Rybelsus® tablet results.

The Company is unaware whether the in-mouth dissolvable tablet product format has ever been used before to attempt to deliver a GLP-1 drug. As such, there was a real possibility that it would fail to do so. Instead, it delivered roughly one-quarter to one-third of the quantity of drug into blood as the Rybelsus® tablet. If this absorption is additive to the existing gastrointestinal absorption, this could be a very interesting incrementally positive result.

This was the first Study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically through the sublingual/buccal tissues of the mouth and throat with some effective drug delivery into the bloodstream.

As this published study notes, the level of expected weight loss associated with GLP-1 drugs is directly correlated with the quantity of GLP-1 drug circulating in the blood stream. It is for this reason that Lexaria is constantly pursuing any and all improvements in drug delivery that are possible.

About the Study
Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was allowed pre-dosing and fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.

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 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

Trend toward higher overall absorption under fed conditions evidenced with DehydraTECH®-processed Rybelsus®

KELOWNA, BC / August 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that the first results from human pilot study #2, GLP-1-H24-2 (the "Study"), have been received. Lexaria's DehydraTECH®-processed Rybelsus® evidenced a trend toward higher overall absorption compared to Rybelsus® that was not processed with DehydraTECH.

Since Lexaria has already demonstrated superior pharmacokinetic performance of its DehydraTECH-processed Rybelsus® under the recommended dosing conditions on an empty stomach in previously announced human pilot study #1, GLP-1-H24-1, it was deemed to be of scientific interest to learn whether the DehydraTECH advantages were also experienced under fed conditions. The DehydraTECH-processed Rybelsus® evidenced higher semaglutide levels in 17 of the 19 blood draws taken until the 24-hour completion of the study averaging 18.8% higher semaglutide levels over the course of the study compared to Rybelsus® alone, although the differences were variable and not significant statistically with such a small sample size.

The two arms of the Study being reported today compared equal 7 mg semaglutide doses from a Rybelsus® swallowed tablet versus a DehydraTECH-processed Rybelsus® swallowed capsule. The volunteers in this Study were administered the drugs while they were in a "fed" state, as compared to an earlier study that demonstrated a 43% peak blood level improvement wherein the volunteers were administered the drug in a "fasted" state. It should be noted that Novo Nordisk™, the owner and manufacturer of Rybelsus®, recommends taking Rybelsus® on an empty stomach, because studies have shown that Rybelsus administration under fed conditions leads to decreased systemic absorption. Their label reads, "Take RYBELSUS® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)."

Semaglutide Absorption (nmol/l)

Time (minutes)

Rybelsus®

DehydraTECH Rybelsus®

Difference (%)

0

0.00

0.00

N/A

20

0.00

0.48

N/A

40

0.36

1.06

196.9%

60

1.24

1.63

31.3%

80

1.70

2.12

24.8%

100

2.54

2.60

2.2%

120

3.13

3.12

-0.4%

140

3.50

3.80

8.6%

160

3.86

4.13

7.2%

180

4.27

4.49

5.2%

210

4.64

4.98

7.2%

240

5.02

5.47

8.8%

300

5.64

6.23

10.4%

360

6.21

6.67

7.3%

420

6.64

6.97

4.8%

480

7.12

7.20

1.1%

540

7.39

7.39

0.0%

600

7.61

7.61

0.0%

24 Hrs

3.77

3.92

4.1%

Average

3.93

4.20

18.8%

"Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the Study on schedule," said Chris Bunka, Chief Executive Officer of the Company. "The results of these Study arms have shown that DehydraTECH appears to continue to offer pharmacokinetic improvements even when dosed under fed conditions, reinforcing DehydraTECH's beneficial delivery kinetics."

Next steps moving forward in Lexaria's 2024 GLP-1 experimental program will include finalization of our ongoing animal study, which has already produced positive results as previously announced, and continued progress toward initiation of our planned upcoming 12-week chronic human study, which will be conducted under fasted dosing conditions. Data from the tolerability evaluations and the mouth melt absorption Study arm will also be available soon.

About the Study

Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus® tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was allowed pre-dosing and fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.

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 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 is outperforming DehydraTECH-semaglutide

  • Select DehydraTECH-CBD formulations appear to continue to outperform DehydraTECH-semaglutide

KELOWNA, BC / August 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 and can now report on 8-week body weight results from ongoing animal study WEIGHT-A24-1 (the "Study").

This Study is the only study carried out anywhere in the world today, 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 continued outperformance of DehydraTECH-liraglutide compared to DehydraTECH-semaglutide is of particular interest. In this Study, the liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.

Animal Weights (grams)

DehydraTECH Groups

End of Acclimation Period

Day 28

% Change to Day 28

Day 56

% Change to Day 56

A: CBD1

427.9

432.6

+1.10%

438.0

+2.36%

B: CBD2

394.6

393.3

-0.33%

386.1

-2.15%

C: CBD3

416.0

408.8

-1.72%

407.3

-2.08%

D: CBD4

431.2

431.7

+0.11%

434.2

+0.69%

E: Rybelsus1

w/SNAC

394.9

394.6

-0.06%

401.4

+1.65%

F: Rybelsus2

w/SNAC

406.2

409.1

+0.70%

406.7

+0.11%

G: Semaglutide

No SNAC

394.2

394.8

+0.15%

399

+1.21%

H: Liraglutide

No SNAC

392.2

385.7

-1.65%

373.6

-4.74%

Average

407.1

406.3

-0.21%

405.8

-0.37%

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

For context, in Lexaria's diabetic animal study DIAB-A22-1 reported on March 2, 2023, the obese control group of animals that received no treatment, experienced 3.04% weight gain during the first 28 days of that study.

DehydraTECH-CBD groups B and C are also outperforming all of the Rybelsus® and semaglutide DehydraTECH composition groups regardless of whether the semaglutide has or has not been processed with the salcaprozate sodium technology known as "SNAC". Lexaria is strongly encouraged by the robust performance achieved so far from its DehydraTECH-CBD.

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 should provide directional evidence for additional future work.

During the initial acclimation phase of 34 days before the beginning of dosing, the animals gained 10.9% body weight on average. Actual weight decreases or slower rates of weight gain have since been achieved in the 8 weeks of dosing in all Study groups receiving DehydraTECH drug therapies.

The Study is ongoing and additional results are expected.

About the Study
Study WEIGHT-A24-1 is underway using diabetic, pre-conditioned Zucker rats. Each arm of the Study is expected to be dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples will be 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

  • DehydraTECH-liraglutide is showing apparent superiority to DehydraTECH-semaglutide

  • Select DehydraTECH-CBD formulations are showing apparent superiority to DehydraTECH-GLP-1 at 4 and 8 weeks

KELOWNA, BC / August 21, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received 4-week and 8-week blood glucose results from ongoing animal study WEIGHT-A24-1 (the "Study").

DehydraTECH-liraglutide (Group H) and two DehydraTECH-CBD formulations (Groups A & B) were the top performers in the Study at day 56, with blood sugar level reductions of 2.50%, 1.90% and 1.53% respectively. This appears to support Lexaria's belief that DehydraTECH-CBD may have utility, especially if used together with a GLP-1 drug, in diabetic control. Animal testing of combination DehydraTECH-CBD with DehydraTECH-GLP-1 drugs is ongoing and in the final phases of the Study.

For context, in Lexaria's diabetic animal study DIAB-A22-1 reported on March 2, 2023, the obese control group of animals that received no treatment experienced 16.7% blood sugar concentration increases, relative to baseline by day 56 of that study. In the current Study, each of the 8 active groups of animals either experienced a smaller increase, or an actual decrease in blood sugar level relative to baseline as compared to the obese control group in the previous study. Interestingly, none of the animals receiving semaglutide experienced actual decreases by day 56 although some decreases were observed at day 28.

Blood Sugar Levels (nmol/L)

DehydraTECH Groups

Day 7 Baseline

Day 28

% Change to Day 28

Day 56

% Change to Day 56

A: CBD1

27.4

26.2

-4.31

26.9

-1.90

B: CBD2

28.4

29.2

4.05

26.6

-1.53

C: CBD3

26.4

24.9

-5.99

27.1

2.46

D: CBD4

24.6

27.9

13.16

26.8

8.94

E: Rybelsus1
w/SNAC

26.4

25.5

-3.60

26.8

1.33

F: Rybelsus2
w/SNAC

24.9

26.8

7.70

26.4

5.96

G: Semaglutide
No SNAC

26.3

25.9

-1.52

27.8

5.54

H: Liraglutide
No SNAC

26.4

25.8

-2.08

25.2

-2.50

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

The continued relative outperformance of DehydraTECH liraglutide is extremely interesting, in part because of Lexaria's proprietary DehydraTECH technology and its applicability to GLP-1 molecules. In other human studies, semaglutide tends to outperform liraglutide in blood sugar control, when not processed with DehydraTECH.

Liraglutide is currently available commercially by Novo Nordisk® sold under the brand names Victoza® and Saxenda®, but the related patents have begun to expire and open the door to new competitors. For example, Teva Pharmaceutical Industries Ltd® recently launched the first generic injectable version of this GLP-1 drug. Although liraglutide was administered as an oral DehydraTECH-enabled dose in this Study, it is currently only sold and prescribed as a subcutaneous injection (see below for more context).

The Study is ongoing and additional results are expected soon.

About Liraglutide
Liraglutide is owned by Novo Nordisk® and sold under the Victoza® and Saxena® brands which generated $1.6 billion in combined revenue in 2022. Liraglutide is currently administered only by injection, after attempts to utilize the sodium salcaprozate ("SNAC") technology found in semaglutide (and sold as the oral tablet Rybelsus®) failed to deliver sufficient performance to enable an oral form factor.

Previous investigators reported that "the absorption enhancing action of SNAC is thought to be highly dependent on the specific agent it is enhancing, which means that carefully tailored co-formulation is required rather than co-administration. The structure of liraglutide (a structurally distinct analog of GLP-1RA) was found to be unfavorable for co-formulation with SNAC on account of its stronger membrane-binding properties, which reduced transcellular passage, as well as its greater tendency to oligomerize, which countered the monomerizing effects of SNAC. In a preclinical study, plasma exposure was significantly higher for semaglutide than liraglutide after oral dosing with SNAC."

About the Study
Study WEIGHT-A24-1 is underway using diabetic, pre-conditioned Zucker rats. Each arm of the Study is expected to be dosed for a 12-week period following the initial 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 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 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

Monomeric form of GLP-1 drug preserved by DehydraTECH

KELOWNA, BC / August 19, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces positive findings from its applied research program together with the National Research Council of Canada ("NRC") that evaluated important mode of action facets of DehydraTECH processed with the glucagon-peptide 1 ("GLP-1") drug, semaglutide.

This highly technical work program examined the molecular properties of DehydraTECH-processed pure semaglutide in comparison to the commercially available semaglutide formulation Rybelsus® using simulated gastric fluid and thereby mimicking conditions in the human gut. A battery of testing methods were employed, including polyacrylamide gel electrophoresis ("PAGE"), size exclusion chromatography ("SEC"), electrospray ionization mass spectrometry ("ESI-LCMS") and dynamic light scattering ("DLS").

Findings from the PAGE and SEC analyses in particular clearly showed not only that semaglutide was efficiently released in the simulated gastric fluid environment with each of two formulations tested, but also that the semaglutide in both formulations was likely in monomeric form. This result is compelling because the available published literature describing Rybelsus® notes that it occurs in simple monomeric form in the human gut due to its proprietary salcaprozate sodium ("SNAC") ingredient chemistry.

This property is important because it allows for permeation of the gastric epithelium for delivery systemically by resisting a tendency to otherwise complex in the gut into larger oligomeric form. Therefore, it is encouraging that Lexaria's DehydraTECH technology also appears to achieve the desired monomeric form without the presence of SNAC.

Novo Nordisk® paid a total of ~US$1.8 billion in 2020 to acquire the SNAC technology that is now utilized within Rybelsus® tablets.

Findings from the DLS and ESI-LCMSS testing were less conclusive experimentally, although the latter also appeared to show monomerization of the semaglutide samples similar to the PAGE and SEC analyses.

These findings help to build upon Lexaria's growing dataset around DehydraTECH amenability to GLP-1 formulation and oral delivery performance. Further experimentation is under consideration with Lexaria's partners at the NRC to expand upon this work, possibly including experimentation under additional parameters mimicking human gut conditions.

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 appears to work with a second GLP-1 drug - liraglutide

  • DehydraTECH appears to be working with semaglutide both with and without SNAC technology

  • DehydraTECH-CBD is showing strong apparent performance relative to GLP-1

  • Dosing in the final four study arms has now begun

KELOWNA, BC / July 17, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that interim results from the first four weeks of dosing in its ongoing diabetes animal study WEIGHT-A24-1 (the "Study") have been received and have already produced several noteworthy findings.

Unlimited food and water has been provided to the animals for the entire duration of the Study. During the initial acclimation phase of 34 days before the beginning of dosing, the animals gained 10.9% body weight on average. During the subsequent 28 days of DehydraTECH-processed drug therapy dosing, all test articles showed either a stark decrease in the rate of body weight gain or, in select cases, the beginning of body weight reduction. DehydraTECH-CBD formulation 3 ("CBD3") and DehydraTECH-liraglutide have produced the largest weight loss results thus far of -1.50% and -1.58%, respectively. Of note, only in Study arms A, B, C, and E did any individual animals lose 5.0% or more body weight during these first 28 days of treatment. An additional 56 days of dosing remains across all treatment groups.

Animal Weights (grams)

DehydraTECH Groups

Arrival in Lab

End of Acclimation Period

% Change to End of Acclimation

End of 28 Days of Dosing

% Change to Day 28

A: CBD1

386.0

427.9

+10.9%

432.6

+0.96%

B: CBD2

360.6

394.6

+9.4%

393.3

-0.59%

C: CBD3

375.5

416.0

+10.8%

408.8

-1.50%

D: CBD4

377.2

431.2

+14.3%

431.7

+0.32%

E: Rybelsus1

365.1

394.9

+8.2%

394.6

+0.07%

F: Rybelsus2

364.5

406.2

+11.4%

409.1

+0.72%

G: Semaglutide

352.7

394.2

+11.8%

394.8

+0.16%

H: Liraglutide

354.6

392.2

+10.6%

385.7

-1.58%

Average

367.0

407.1

+10.9%

406.3

-0.18%

Notes

-Weights shown are average of six animals per group.

- Groups A through D were varying DehydraTECH-CBD compositions

- Groups E and F were reformulated Rybelsus® compositions including DehydraTECH and the sodium salcaprozate ("SNAC") technology

- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) without SNAC inclusion

This is the first time that DehydraTECH processing was applied to the GLP-1 drug liraglutide, and it is encouraging to witness its relative outperformance. Although liraglutide was administered as an oral DehydraTECH-enabled dose in this Study, it is currently only sold and prescribed as a subcutaneous injection (see below for more context). Liraglutide is currently available commercially by Novo Nordisk® sold under the brand names Victoza® and Saxenda®, but the related patents have begun to expire and open the door to new competitors. For example, Teva Pharmaceutical Industries Ltd® recently launched the first generic injectable version of this GLP-1 drug.

Study arm G is the first time that pure semaglutide was tested with DehydraTECH processing without the SNAC technology found within the Rybelsus® tablets. It is of interest that it has, so far, apparently performed nearly identically in body weight gain attenuation to Study arm E which is the best performing DehydraTECH-processed reformulated Rybelsus® composition that includes the SNAC technology.

Another important objective has now been reached in evaluating the results of the first 28 days of dosing among the first eight Study arms that, together, constitute Cohort 1 of the Study: Performance superiority has been observed among the various formulations, allowing the Study team to select the best performers for inclusion in the subsequent Cohort 2 Study work. Dosing in those final four Study arms that constitute Cohort 2 of the Study has begun and is expected to be completed in mid-October.

Those final four Study arms include a positive control arm (commercially available Rybelsus®) and a placebo arm, as well as a combined DehydraTECH-semaglutide with DehydraTECH-CBD arm (Groups C + E), and a combined DehydraTECH-liraglutide with DehydraTECH-CBD arm (Groups C + H).

In all cases and as per design in an exploratory, directionally informative Study of this nature, animal populations were not intended to be large enough to necessarily evidence statistical significance, and readers are reminded that these data are indicative only of apparent trends that have not been analysed statistically. Blood glucose data for the first four weeks of dosing has also been received, is being processed, and will be released soon. Pharmacokinetic ("PK") data for the first four weeks has not arrived yet and will be released when available.

Brain absorption data can only be collected at the end of the 12-week study and will also be released when available. Readers are encouraged to review our May 17, 2024 press release that provides a thorough explanation of the comprehensive Study design and rationale, including why possible enhancement of brain absorption is believed to be of potential significance.

About Liraglutide

Liraglutide is owned by Novo Nordisk® and sold under the Victoza® and Saxena® brands which generated $1.6 billion in combined revenue in 2022. Liraglutide is currently administered only by injection, after attempts to utilize the SNAC technology found in semaglutide (and sold as the oral tablet Rybelsus®) failed to deliver sufficient performance to enable an oral form factor.

Previous investigators reported that "the absorption enhancing action of SNAC is thought to be highly dependent on the specific agent it is enhancing, which means that carefully tailored co-formulation is required rather than co-administration. The structure of liraglutide (a structurally distinct analog of GLP-1RA) was found to be unfavorable for co-formulation with SNAC on account of its stronger membrane-binding properties, which reduced transcellular passage, as well as its greater tendency to oligomerize, which countered the monomerizing effects of SNAC. In a preclinical study, plasma exposure was significantly higher for semaglutide than liraglutide after oral dosing with SNAC."

About the Study

Study WEIGHT-A24-1 is underway using diabetic, pre-conditioned Zucker rats. Each arm of the Study is expected to be dosed for a 12-week period following the initial 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 PK drug delivery analyses. 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.

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

Strategic growth plan execution underway.

KELOWNA, BC / July 16, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces plans for strategic growth.

"Lexaria has certain initiatives underway that are increasing confidence in our medium-term and longer-term strategies," said Chris Bunka, Chief Executive Officer of Lexaria Bioscience Corp. "As a result of the success we are experiencing and the continued success we are anticipating, we will be implementing a number of strategic steps in the weeks and months to come."

Lexaria will be expanding its management team this summer as it prepares for the greater workload of multiple projects and initiatives. The first step is appointing Nelson Cabatuan as our consulting Chief Strategic Financial Advisor, in order to maximize his skills in the fields of corporate finance and strategic industry relationships and opportunities. Nelson is resigning from his current role as Chief Financial Officer (CFO) in order to better focus on the strategic opportunities afforded to the Company outside of typical accounting tasks. Our new CFO will be appointed and announced in due course.

The Company is also in the conceptual design stages of additional R&D projects related to additional GLP-1 molecules of interest, beyond those previously disclosed. Announcements about additional R&D studies may be made over the next several months. Finally, Lexaria is closely examining its Phase 1b hypertension study, that has already received clearance to proceed from the FDA, for more concrete steps to launch that study, subject to funding, as soon as possible.

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

All three dosing arms have been completed.

KELOWNA, BC / July 9, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX & LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that human pilot study #2, GLP-1-H24-2, (the "Study") has now completed all dosing.

The Study is a three-arm, crossover investigation comparing three 7 mg semaglutide dose formulations:

  1. a positive control Rybelsus® swallowed tablet;

  2. DehydraTECH-semaglutide swallowed capsules; and

  3. for the first time ever, an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.

The final DehydraTECH Study arm used a Rybelsus® composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database ("FDA IID"), delivered within an in-mouth dissolvable tablet. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can absorb at any level systemically through the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective drug delivery into the bloodstream. This is being explored because of the acidic environment of the stomach that seriously degrades GLP-1 drugs that are swallowed, resulting in exceptionally low blood absorption rates of less than 1% when an absorption technology is not used.

All blood samples collected during the study are now being transported to the bioanalytical lab for analysis. We anticipate completing the analysis and announcing the Study results in late August or early September. Next steps include our evaluation and optimization of different semaglutide formulations in our already-underway animal study, as well as evaluation of semaglutide in our upcoming 12-week chronic human study.

"Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the Study on schedule," said Chris Bunka, Chief Executive Officer of the Company. "The results of this Study are expected to validate our earlier work with semaglutide, and also to discover whether it is possible to achieve any absorption of this market-leading GLP-1 drug through the tissues of the mouth."

In the previously announced human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic ("PK") oral delivery performance of the DehydraTECH-enhanced GLP-1 drug semaglutide available commercially in the branded product Rybelsus®.

About the Study

Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus®tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.

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 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

Lexaria currently holding 46 granted patents worldwide

KELOWNA, BC / July 8, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces three new patent awards.

In the European Union, the Company has received a new granted patent in Lexaria's patent family #6: Transdermal and/or Dermal Delivery of Lipophilic Active Agents. This is the Company's second granted patent in this patent family with an earlier patent granted in Canada. This patent will expire in 2039, if not extended and was validated in the following countries: Austria, Czech Republic, France, UK, Germany, Italy, Poland, Spain, Sweden and Switzerland.

In Canada, Lexaria has received a new granted patent in patent family #18: Compositions and Methods for Enhanced Delivery of Antiviral Agents. This is the Company's fourth granted patent in this patent family which was previously granted in the US, Australia, and Japan. This patent will expire in 2041 if not extended.

This patent builds on original research conducted by Lexaria in 2021 wherein the Company evidenced in animal studies that DehydraTECH processing of five different antiviral drugs belonging to three classes of drugs (Protease Inhibitors, Reverse Transcriptase Inhibitors, and Tubulin Polymerization and Microtubule Inhibitor) all were delivered into bloodstream at rates from 42% improvement to 204% improvement, compared to the same drugs not processed with DehydraTECH.

Building on prior patent success in the US related to epilepsy, Lexaria has received its fourth granted US patent in patent family #24, Compositions and Methods for Treating Epilepsy. This patent complements earlier research that discovered DehydraTECH-CBD was capable of mitigating epileptic seizures in rodents, and was also absorbed into the bloodstream more effectively than the commercially available cannabinoid-based anti-seizure medication, Epidiolex®. This patent will expire in 2044 if not extended.

With the issuance of these three new patents, Lexaria's patent portfolio has now grown to 46 granted patents worldwide. Lexaria's intellectual property remains a significant component in supporting future business objectives.

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.



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