Positive 8-Week Body Weight Results from Lexaria's GLP-1 Diabetes Animal Study

Rhea-AI Summary

Lexaria Bioscience Corp. (NASDAQ:LEXX) has released 8-week body weight results from its ongoing animal study WEIGHT-A24-1. The study evaluates the performance of DehydraTECH-processed liraglutide and semaglutide, as well as various DehydraTECH-CBD formulations. Key findings include:

1. DehydraTECH-liraglutide (Group H) showed the most significant weight loss at -4.74%.

2. Two DehydraTECH-CBD formulations (Groups B and C) outperformed DehydraTECH-semaglutide and Rybelsus compositions.

3. All DehydraTECH drug therapies resulted in weight decreases or slower weight gain compared to the initial acclimation phase.

The study is ongoing, with additional results expected. Lexaria cautions against direct comparisons to human weight loss studies due to the unlimited food and water provided to the animals.

Positive

• DehydraTECH-liraglutide showed the highest weight loss of -4.74% over 56 days
• Two DehydraTECH-CBD formulations outperformed DehydraTECH-semaglutide and Rybelsus compositions
• All DehydraTECH drug therapies resulted in weight decreases or slower weight gain

Negative

• None.

Insights

Medical Research Analyst

The 8-week body weight results from Lexaria's GLP-1 diabetes animal study reveal intriguing findings. DehydraTECH-liraglutide demonstrates superior performance compared to DehydraTECH-semaglutide, with a 4.74% weight reduction. This is particularly noteworthy given that semaglutide is typically more effective for weight loss in humans. The oral administration of liraglutide, traditionally an injectable drug, suggests potential for improved patient convenience.

Interestingly, certain DehydraTECH-CBD formulations (groups B and C) show promising results, outperforming Rybelsus and semaglutide compositions. This hints at CBD's potential role in weight management, warranting further investigation. However, it's important to note that these are animal studies with unlimited food access, which may not directly translate to human outcomes. The study's primary value lies in comparing relative performance between groups, guiding future research directions in GLP-1 and CBD-based therapies for diabetes and weight management.

Financial Analyst

Lexaria's study results could have significant implications for its market position and financial outlook. The outperformance of DehydraTECH-liraglutide over DehydraTECH-semaglutide is particularly noteworthy, as it could potentially disrupt the current GLP-1 market dominated by semaglutide-based products. If these results translate to human trials, Lexaria could capture a substantial share of the rapidly growing GLP-1 market, estimated to reach $50 billion by 2030.

Moreover, the promising performance of DehydraTECH-CBD formulations opens up additional market opportunities in the expanding CBD therapeutics sector. This diversification could enhance Lexaria's revenue streams and reduce dependency on a single product line. However, investors should remain cautious as these are early-stage animal studies and the path to commercialization involves significant regulatory hurdles and further clinical trials. The company's ability to secure partnerships or funding for advanced human trials will be important for realizing the potential value of these preliminary findings.

• DehydraTECH-liraglutide is outperforming DehydraTECH-semaglutide

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

KELOWNA, BC / ACCESSWIRE / 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
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.

View the original press release on accesswire.com

FAQ

What were the key findings of Lexaria's (LEXX) 8-week body weight study?

The key findings were: DehydraTECH-liraglutide showed the highest weight loss at -4.74%, two DehydraTECH-CBD formulations outperformed DehydraTECH-semaglutide and Rybelsus compositions, and all DehydraTECH drug therapies resulted in weight decreases or slower weight gain compared to the initial acclimation phase.

How did DehydraTECH-liraglutide perform in Lexaria's (LEXX) animal study?

DehydraTECH-liraglutide (Group H) showed the most significant weight loss at -4.74% over 56 days, outperforming other formulations in the study.

What is the significance of DehydraTECH-CBD's performance in Lexaria's (LEXX) weight loss study?

Two DehydraTECH-CBD formulations (Groups B and C) outperformed all Rybelsus and semaglutide DehydraTECH compositions, indicating potential effectiveness in weight management.

When can we expect additional results from Lexaria's (LEXX) WEIGHT-A24-1 study?

The study is ongoing, and Lexaria has stated that additional results are expected, although no specific timeline was provided in the press release.