Positive Partial 12-Week Body Weight Results from Lexaria’s GLP-1 Diabetes Animal Study

Rhea-AI Summary

Lexaria Bioscience Corp. (NASDAQ:LEXX) has released partial 12-week body weight results from its animal study WEIGHT-A24-1. The study evaluated various DehydraTECH formulations, including CBD and GLP-1 drugs. Key findings include:

1. DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top-performing weight loss groups.

2. All DehydraTECH groups experienced accelerated rates of weight loss during the final 4 weeks of the study.

3. DehydraTECH-liraglutide outperformed DehydraTECH-semaglutide, which is notable given semaglutide's typically higher effectiveness in humans.

4. Lexaria has filed patent applications for the unique performance of liraglutide processed with DehydraTECH.

The company awaits additional data, including blood glucose findings and pharmacokinetic results.

Positive

• DehydraTECH-liraglutide and select DehydraTECH-CBD formulations showed superior weight loss performance
• Accelerated weight loss rates observed in all DehydraTECH groups during the final 4 weeks
• DehydraTECH-liraglutide outperformed DehydraTECH-semaglutide, despite semaglutide's typically higher effectiveness
• Patent applications filed for unique performance of DehydraTECH-processed liraglutide
• Potential for oral administration of liraglutide, which is typically injected

Negative

• Delays in receiving additional study data due to third-party laboratory issues
• comparability to human weight loss studies due to unlimited food and water provided to animals

Insights

Pharmaceutical Research Analyst

The results from Lexaria's GLP-1 diabetes animal study show promising outcomes for their DehydraTECH delivery technology, particularly with liraglutide and CBD formulations. Key points:

• DehydraTECH-liraglutide and select DehydraTECH-CBD groups outperformed Rybelsus® and semaglutide formulations in weight loss
• Accelerated weight loss observed in all DehydraTECH groups during the final 4 weeks
• First study to evaluate liraglutide with DehydraTECH, showing notable performance against semaglutide
• Patent applications filed for DehydraTECH-processed liraglutide

These results could potentially lead to improved oral delivery of GLP-1 drugs, a $1.656 billion market (Victoza® sales). However, caution is warranted as animal studies don't directly translate to human outcomes. Pending blood glucose and pharmacokinetic data will be important for a comprehensive evaluation. If successful, this could significantly impact the diabetes and weight loss drug market.

Market Analyst

This news is potentially significant for Lexaria Bioscience Corp. (NASDAQ:LEXX), a small-cap company with a market cap of $43.48 million. Key market implications:

• Positive results in the GLP-1 space could attract big pharma interest, given the booming market for diabetes and weight loss drugs
• Outperformance of DehydraTECH-liraglutide over semaglutide formulations is noteworthy, as semaglutide is the active ingredient in highly successful drugs like Ozempic® and Wegovy®
• Patent applications for DehydraTECH-processed liraglutide could create valuable intellectual property
• Potential for improved oral delivery of GLP-1 drugs could disrupt the current market dominated by injectable formulations

Investors should monitor upcoming data releases, especially blood glucose findings and pharmacokinetic results. While promising, it's important to note that this is an early-stage animal study and significant development work would be required before any potential commercialization. The stock may see increased volatility as the market digests this information.

• DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing weight loss groups

• Accelerated rates of weight loss were experienced during the final 4 weeks of the study in all DehydraTECH groups

KELOWNA, BC / ACCESSWIRE / October 22, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) body weight results from the recently completed animal study WEIGHT-A24-1 (the "Study").

Animal Weights (grams)

DehydraTECH Groups	End of Acclimation Period	Day 28	% Change to Day 28	Day 56	% Change to Day 56	Day 84	% Change to Day 84
A: CBD1	427.9	432.6	+1.10%	438.0	+2.36%	432.3	+1.046%
B: CBD2	394.6	393.3	-0.33%	386.1	-2.15%	374.9	-4.996%
C: CBD3	416.0	408.8	-1.72%	407.3	-2.08%	402.5	-3.237%
D: CBD4	431.2	431.7	+0.11%	434.2	+0.69%	419.0	-2.829%
E: Rybelsus1 w/SNAC	394.9	394.6	-0.06%	401.4	+1.65%	393.6	-0.321%
F: Rybelsus2 w/SNAC	406.2	409.1	+0.70%	406.7	+0.11%	403.1	-0.780%
G: Semaglutide No SNAC	394.2	394.8	+0.15%	399.0	+1.21%	394.1	-0.017%
H: Liraglutide No SNAC	392.2	385.7	-1.65%	373.6	-4.74%	369.1	-5.880%
Average	407.1	406.3	-0.21%	405.8	-0.37%	398.6	-2.127%

Notes

• Groups A through D were different DehydraTECH-CBD compositions

• Groups E and F were reformulated Rybelsus® DehydraTECH compositions

• Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions

• Recalculations led to slight changes from earlier reported data

Lexaria is strongly encouraged that the DehydraTECH-liraglutide and select DehydraTECH-CBD groups B, C, and D outperformed all three of the Rybelsus® and semaglutide DehydraTECH composition groups regardless of whether the semaglutide had or had not been processed with the salcaprozate sodium technology known as "SNAC". Rybelsus®, which utilizes Novo Nordisk's proprietary SNAC technology, is the world's only orally administered GLP-1 drug brand.

This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. In humans, semaglutide has been shown in other studies to be more than twice as effective at promoting weight loss as liraglutide . Thus, the outperformance of DehydraTECH-liraglutide compared to DehydraTECH-semaglutide is of notable interest. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.

Teva Pharmaceuticals (NYSE:TEVA) on June 24, 2024, announced the authorized launch of a generic version of Novo Nordisk's Victoza® as injected liraglutide and noted that Victoza had annual sales of $1.656 billion as of April, 2024.

Lexaria notes that it has already filed patent applications to recognize the unique outperformance of liraglutide once processed with DehydraTECH delivery technology.

Readers are cautioned to not compare results of this animal study to human weight loss studies , primarily because unlimited food and water has been provided to the animals for the entire duration of this Study. Offered unlimited food, many rats will reach morbid obesity.

The primary value in this Study is the relative performance of the different Study groups, which has provided directional evidence for additional future work. For context, in an older Lexaria diabetic animal study DIAB-A22-1 reported on March 2, 2023 , the obese control group of animals that received no drug treatment , experienced 3.04% weight gain during the first 28 days of that study.

During the initial acclimation phase of 34 days before the beginning of dosing in this Study, the animals gained 10.9% body weight on average. Actual weight decreases or slower rates of weight gain have since been achieved in the 12 weeks of dosing in all Study groups receiving DehydraTECH drug therapies. Importantly, accelerated rates of weight loss were experienced in all DehydraTECH groups during the final 4 weeks of the study.

Additional data from this Study is pending including blood glucose findings from the animals reported herein, as well as body weight and blood glucose findings from the second study cohort that included positive and vehicle (placebo) control arms. Analyses of brain and blood absorption pharmacokinetic results is also underway, although unforeseen delays at the third-party laboratories involved is affecting timing of completion of this work. Lexaria is working with these laboratories to minimize further delays and will report on these data as soon as possible.

About the Study

Study WEIGHT-A24-1 was completed using diabetic, pre-conditioned Zucker rats. Each arm of the Study was dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples were collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups are offered unlimited access to food throughout the course of the Study.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com .

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
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 main findings of Lexaria's GLP-1 diabetes animal study?

The main findings were that DehydraTECH-liraglutide and select DehydraTECH-CBD formulations showed the best weight loss performance, and all DehydraTECH groups experienced accelerated weight loss in the final 4 weeks of the 12-week study.

How did DehydraTECH-liraglutide perform compared to other formulations in the LEXX study?

DehydraTECH-liraglutide outperformed all three Rybelsus® and semaglutide DehydraTECH composition groups, which is notable given that semaglutide is typically more effective for weight loss in humans.

What potential advantages does Lexaria's DehydraTECH technology offer for GLP-1 drugs?

DehydraTECH technology potentially allows for oral administration of drugs like liraglutide, which are typically injected. It also showed improved weight loss performance compared to existing oral GLP-1 formulations in the animal study.

What is the significance of Lexaria (LEXX) filing patent applications for DehydraTECH-processed liraglutide?

The patent applications aim to protect the unique outperformance of liraglutide when processed with DehydraTECH delivery technology, potentially securing Lexaria's intellectual property in this promising area of drug delivery.