Positive Partial 12-Week Blood Sugar Results from Lexaria’s GLP-1 Diabetes Animal Study

Rhea-AI Summary

Lexaria Bioscience (NASDAQ:LEXX) announces partial 12-week blood sugar results from their animal study WEIGHT-A24-1. The study evaluated DehydraTECH-processed formulations of CBD, liraglutide, semaglutide, and Rybelsus. Among eight study groups, DehydraTECH-liraglutide (Group H) showed the most significant reduction in blood sugar levels (-11.54%), followed by DehydraTECH-CBD Group B (-3.76%). This marks the first-ever evaluation of DehydraTECH-processed liraglutide, with notably strong performance compared to other groups. Additional data, including body weight, blood glucose findings, and pharmacokinetic results, are pending from third-party laboratories.

Positive

• DehydraTECH-liraglutide achieved significant blood sugar reduction of 11.54%
• DehydraTECH-CBD Group B demonstrated effective blood sugar reduction of 3.76%
• DehydraTECH formulations outperformed Rybelsus and semaglutide groups

Negative

• Laboratory delays affecting completion of additional study data
• Six out of eight study groups showed no reduction in blood sugar levels

Insights

Medical Research Analyst

The preliminary results from Lexaria's Study WEIGHT-A24-1 show promising developments in oral drug delivery for diabetes treatment. The DehydraTECH-liraglutide formulation achieved an impressive 11.54% reduction in blood sugar levels over 84 days, outperforming both reformulated Rybelsus and pure semaglutide compositions.

The success of DehydraTECH in delivering liraglutide orally is particularly significant, as this GLP-1 drug is traditionally only available via injection (Saxenda/Victoza). If further validated, this could represent a major advancement in diabetes treatment delivery methods. The CBD formulation (Group B) also showed modest effectiveness with a 3.76% reduction in blood sugar levels.

However, investors should note that these are partial results from an animal study and important data including body weight changes, blood glucose findings from the control group and PK analyses are still pending. The true commercial potential will depend on these additional data points and future human trials.

• DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing blood sugar groups

KELOWNA, BC / ACCESSWIRE / October 24, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) blood sugar results from the recently completed animal study WEIGHT-A24-1 (the "Study").

Blood Sugar Levels (mmol/L)
DehydraTECH Groups	Day 7 Baseline	Day 28	% Change to Day 28	Day 56	% Change to Day 56	Day 84	% Change to Day 84
A: CBD1	27.4	26.2	-4.31%	26.9	-1.90%	27.7	1.09%
B: CBD2	28.4	29.2	2.73%	26.6	-6.22%	27.3	-3.76%
C: CBD3	26.4	24.9	-5.99%	27.1	2.46%	27.5	3.85%
D: CBD4	24.6	27.9	13.16%	26.8	8.94%	27.0	9.75%
E: Rybelsus1	26.4	25.5	-3.60%	26.8	1.33%	26.8	1.59%
w/SNAC
F: Rybelsus2	24.9	26.8	7.70%	26.4	5.96%	27.3	9.58%
w/SNAC
G: Semaglutide	26.3	25.9	-1.52%	27.8	5.54%	26.9	2.13%
No SNAC
H: Liraglutide	26.4	25.8	-2.08%	25.2	-4.56%	23.3	-11.54%
No SNAC

Notes

- Groups A through D were different DehydraTECH-CBD compositions

- Groups E and F were reformulated Rybelsus DehydraTECH compositions

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

- Recalculations led to slight changes from earlier reported data

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

Study data for four additional animal groups (I, J, K, and L), including a positive control group of Rybelsus® that has not been processed with DehydraTECH, will be available soon. Of the eight Study groups reported on today, DehydraTECH-CBD group B and the sole DehydraTECH-liraglutide group H were both successful in reducing blood sugar levels, while the other six groups, including all three of the Rybelsus® and pure semaglutide DehydraTECH composition groups, were not.

This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. Thus, the outperformance of DehydraTECH-liraglutide compared to the other groups is of notable interest and was unexpected. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda® or Victoza®.

Usually, injected versions of drugs have greater efficacy than orally administered versions of the same drug because of superior pharmacokinetics ("PK"). Lexaria's DehydraTECH drug delivery technology has historically enhanced the PK of orally administered drugs, opening a potential for viability in commercial markets.

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

About the Study

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

About Lexaria Bioscience Corp. & DehydraTECH

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

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
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 blood sugar reduction results for LEXX's DehydraTECH-liraglutide in the 12-week study?

DehydraTECH-liraglutide (Group H) achieved an 11.54% reduction in blood sugar levels over the 84-day study period.

How many groups showed successful blood sugar reduction in LEXX's WEIGHT-A24-1 study?

Only two out of eight groups showed successful blood sugar reduction: DehydraTECH-CBD group B and DehydraTECH-liraglutide group H.

How did LEXX's DehydraTECH-processed formulations compare to Rybelsus in the study?

DehydraTECH-liraglutide and DehydraTECH-CBD groups A and B outperformed all Rybelsus and pure semaglutide DehydraTECH composition groups.