American Marconi Wireless News - Lexaria Releases Additional Results from its Successful Phase 1b Study GLP-1-H24-4

"We are pleased to report additional data from our first Phase 1b clinical study," stated Richard Christopher, CEO of Lexaria. "It adds to a growing dataset which showcases the many potential benefits of our platform technology - DehydraTECH."

"At our stage of development, clinical data is of paramount importance to us," continued Mr. Christopher. "Lexaria's "follow the science" approach and the positive results from this Study are already guiding our 2026 R&D plans as well as our business development initiatives. We are expecting exciting developments in 2026 and beyond."

Secondary Efficacy Parameters
At week 16, rough parity was reached between the DHT arms and the Rybelsus® control as there were no statistically significant treatment differences observed in terms of the numerical least squares means ("LSM") changes from baseline in the secondary efficacy parameters of mean fasting glucose, cholesterol, and low density lipoprotein ("LDL") cholesterol specifically (nominal p-values were >0.05).

Body Composition
While both DHT-semaglutide and Rybelsus® reduced body weight during the Study, it was noteworthy that upon a separate body composition analysis performed in the Study using the dual-energy, X-ray absorptiometry / Bioelectrical Impedance Analysis methodology, at week 12, the DHT‑semaglutide arm showed a modest numerical LSM reduction in fat mass of −1.08 kg and in total mass of −1.40 kg, accompanied by minimal reduction in lean mass of −0.41 kg. In contrast, the Rybelsus® control arm achieved greater LSM reductions in fat mass of −3.55 kg and in total mass of −5.36 kg, but also had a notably higher reduction in lean mass of −1.72 kg. This finding is considered intriguing as it possibly points to proportionally lower lean mass to fat mass bodyweight reduction potential being achievable with DHT-semaglutide (37.96% as compared to 48.45% for Rybelsus®).

Blood Pressure Analyses
While blood pressure analysis was not formally an efficacy endpoint of the Study, it was noteworthy that the DHT-cannabidiol ("DHT-CBD") arm achieved meaningful reductions in blood pressure. This is of special interest since the Study participants were not generally hypertensive (i.e., hypertension was not a recruitment requirement in this Study).

At week 4, a mean change of −4.6 mmHg in systolic blood pressure and −4.0 mmHg in diastolic blood pressure was evidenced in the DHT-CBD arm. Blood pressure reductions were also evident in this arm following completion of treatment at the week 16 follow up point (4 weeks after cessation of treatment) with a mean change of −2.6 mmHg in systolic blood pressure and −3.0 mmHg in diastolic blood pressure reported.

These findings are very encouraging relative to Lexaria's separate program interests in pursuing development of DHT-CBD for the treatment of hypertensive patients. Lexaria has earlier received FDA clearance to conduct a Phase 1b study to investigate this phenomenon more thoroughly.

Pharmacokinetic Exploratory Analyses
Blood plasma level analyses of CBD, semaglutide and tirzepatide were performed for all patients as applicable using a validated liquid chromatography mass spectrometry ("LCMS") assay. In the DHT‑CBD alone and DHT‑CBD with DHT‑semaglutide arms, plasma CBD concentrations were quantifiable through week 16. In the DHT-tirzepatide arm, plasma tirzepatide concentrations were quantifiable only through week 12, with the maximum plasma concentrations observed at week 8. Plasma semaglutide concentrations were not quantifiable in the DHT-semaglutide and DHT-CBD with DHT-semaglutide arms. This was believed to be due to unforeseen LCMS assay issues affecting blood plasma recovery and detection for DHT-delivered semaglutide, not applicable to the Rybelsus® delivered semaglutide. However, preliminary testing using a separately performed, enzyme-linked immunosorbent assay ("ELISA") upon a subset of patient blood plasma samples from these DHT arms did detect clearly recoverable/measurable semaglutide levels. Based on this, additional testing is in process on the full complement of patient blood plasma samples from these arms.

Short Form 36 Health Survey
The short form 36 health survey ("SF-36") is a widely administered questionnaire designed to allow persons to self-report their perceived health status assessing health-related quality of life parameters across eight domains (i.e., physical/role functioning, bodily pain, general health, vitality, mental health, social functioning). In this Study, participants were asked to complete the SF-36 upon the completion of dosing. Those participants in the Rybelsus® control Study arm reported modest mean improvements ranging from 2.39 to 4.35 points or no changes (neither worsening nor improving); whereas those participants receiving the DHT-semaglutide arm reported mean improvements of >5 points in the physical components and >3 points in the mental components.

It is not known specifically why the DHT-semaglutide participants self-reported better SF-36 survey results than the Rybelsus®-only participants, but it may be at least in part linked to the reduction in adverse events ("AE's"), as noted in our December 23, 2025 press release.

Overall Conclusions and Next Steps
As previously announced, study GLP-1-H24-4 met its primary endpoint objectives showing good safety and tolerability of all DHT test articles with clear reductions in total and gastrointestinal ("GI")-specific AEs relative to the Rybelsus® control arm. The Study demonstrated positive findings across numerous parameters with comparability, and in some instances, superiority to the Rybelsus® control arm.

Shareholders and interested parties should note that the final and complete Study report is in excess of 7,000 pages long. When Lexaria communicates that a great deal of information must be reviewed prior to this public dissemination or via partner review, the enormity of this data set should always be considered.

Based on the findings from this Study, Lexaria considers the DHT-semaglutide test article to be most worthy of continued investigation for the therapeutic indication studied. However, it would seem most prudent for any such work to include the salcaprozate sodium ("SNAC") ingredient chemistry present in Lexaria's DHT-semaglutide formulations originally tested in its previous human clinical studies GLP-1-H24-1 and GLP-1-H24-2, (Human Pilot Studies #1 and #2), but not included in the current Study. These previous human clinical studies evidenced the strongest DHT-semaglutide efficacy performance superior to the Rybelsus® control used therein, while also maintaining improvements in safety and tolerability relatively speaking with the DHT-semaglutide formulation studied.

Moving forward, Lexaria intends to consider its options to perform prospective follow on human clinical testing with a DHT + SNAC + semaglutide composition compared to Rybelsus® accordingly, to expand and build upon the learnings in aggregate from studies GLP-1-H24-1, GLP-1-H24-2 and GLP-1-H24-4. Details will be provided on this if/when Lexaria formalizes plans to perform such a study.

In parallel, now that public release of final results from study GLP-1-H24-4 has occurred, Lexaria is taking steps to proceed with relaying the dataset to the pharmaceutical company ("PharmaCo") that Lexaria has a Material Transfer Agreement ("MTA") in place with. As previously announced, this MTA was recently extended through April 30, 2026 to accommodate time needed for PharmaCo's receipt and review of this dataset, after which time further information will be provided.

Lexaria remains hopeful that achievement of its primary endpoint in the current Study, with DHT evidencing superior safety and tolerability and a significant reduction in GI side effects especially relative to Rybelsus®, will be considered attractive and compelling to PharmaCo in its deliberations about potential next steps in its relationship with Lexaria. This would be consistent with the pharmaceutical industry's strong appetite in the related therapeutic sectors for improvements in unwanted side effects as Lexaria previously reported.

Lexaria was pleased to have recently raised additional capital through financings intended to allow it to fund prospective new development opportunities through the entirety of calendar 2026; the details of which are in the process of being finalized and will be forthcoming in due course. Deployment of these funds may include, but not be limited to, progressing its prospective further human clinical testing upon DHT + SNAC + semaglutide as noted above, as well as supporting other complementary research and development program work in the Glucagon-Like Peptide-1 ("GLP-1") sector.

About the Study
Study GLP-1-H24-4 investigated 126 overweight, obese, pre-diabetic and/or type-2 diabetic human volunteers/patients. The primary endpoint in this study was to assess impacts upon safety and tolerability based on the incidence of treatment emergent adverse events. This Study initially included 3 DHT arms testing DHT-CBD, DHT-semaglutide and a combination of DHT-CBD with DHT-semaglutide. Performance across these three initial study arms was monitored compared to commercially available Rybelsus® as the Study positive control group. Of note, the DHT-semaglutide composition evaluated used pure semaglutide processed without inclusion of the SNAC ingredient found in the Rybelsus® composition differing, therefore, from the DHT-semaglutide composition previously tested by Lexaria in its studies GLP-1-H24-1 and GLP-1-H24-2 that used reformulated commercially available SNAC-inclusive Rybelsus® as the semaglutide active substance input. In addition, this Study was expanded after initiation to incorporate an orally delivered DHT-tirzepatide arm to assess safety, tolerability and effectiveness in an effort to potentially advance the findings discovered with Lexaria's previous DHT-tirzepatide human pilot study GLP-1-H24-3. Of note, however, the DHT-tirzepatide composition evaluated in study GLP-1-H24-4 used pure tirzepatide as the active substance input instead of reformulated commercially available Zepbound® differing, therefore, compared to the composition utilized in study GLP-1-H24-3.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with over 50 patents granted and additional 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 to 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 ACCESS Newswire

S.Gregor--AMWN