Arizona Tribune - Lexaria Announces Positive Final Results From Human Pilot Study #5

KELOWNA, BC / ACCESS Newswire / February 5, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX), (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce final results from Human Pilot Study #5 (GLP-1-H25-5) (the "Study"), which compared oral DehydraTECH-liraglutide ("DHT-LIR") capsules to injected Saxenda^® branded liraglutide ("SAX-LIR").

"We are extremely pleased with the results of Human Pilot Study #5," stated Richard Christopher, CEO of Lexaria. "In addition to achieving the Study's primary safety and tolerability endpoint, we also demonstrated that oral DehydraTECH-liraglutide functioned comparably to traditionally injected liraglutide, consistent with our regulatory development pathway objectives," continued Mr. Christopher. "We now have compiled compelling evidence to further support examining the pursuit of the world's first oral liraglutide product."

The primary results from this Study were issued on June 11, 2025, at which time Lexaria reported a 22.7% reduction in adverse events ("AEs") with DHT-LIR as compared to the SAX-LIR, with a particular emphasis on a 67% reduction in nausea and a 31% reduction in overall gastrointestinal AEs. The differences in measurements of blood glucose, insulin and body weight across most time points were not statistically significantly different, with remarkable similarity in many areas and slight differences in others. Weight loss was experienced by 9 out of 10 people in each Study arm and slightly higher in the Saxenda^® Study arm; though weight loss was not a primary goal of this Study with the very short treatment period of only 1 week with each treatment. Evaluating the safety and tolerability of the oral DHT-LIR capsules relative to injected SAX-LIR was the primary endpoint of this Study. This objective was successfully met with clear signs of improved safety and tolerability performance by the DHT-LIR.

Since mid-2025, Lexaria and its third-party bioanalytical service providers have invested considerable time and expertise in attempting to determine the precise pharmacokinetic ("PK") blood liraglutide quantitation and profiling results from the Study. This included the use of two different manufactured brands of commercially available ELISA (enzyme-linked immunosorbent assay) test kits. Throughout the course of this bioanalytical work, challenges were encountered with background signal noise detection, which complicated our ability to accurately capture blood liraglutide measurements in both the SAX-LIR and DHT-LIR study samples. The background signal noise is believed to be attributable to the fact that liraglutide and other peptide drugs are commonly known to bind with, and have poor separation from, albumin, a naturally occurring protein present in human blood plasma.

In light of this issue, the PK testing from the Study was limited to exploratory visualization of the raw ELISA signals which, nonetheless, over time demonstrated broadly similar temporal patterns between the DHT-LIR and the SAX-LIR. The visualization of the similar signal patterns of the two treatments is consistent with the instances of functional comparability otherwise demonstrated in the Study, pursuant to Lexaria's regulatory development pathway objectives. Lexaria considers this to be particularly noteworthy given the fact that the DHT-LIR dose quantity studied was conservatively low (see "About the Study", below) for this initial human investigation, relative to that of the SAX-LIR, with room for possibly increasing the dose if necessary in potential future studies.

The two most important strategic objectives of this Study were:

1. To discover whether the DehydraTECH processing of liraglutide would work sufficiently enough to potentially allow for an oral version of the drug to be compared to the current injection-only delivery method; and

2. To demonstrate that oral DHT-LIR could produce comparable functional results to the injected version, allowing for an expedited FDA regulatory development pathway known as a 505(b)(2) new drug application (the "505(b)(2) Pathway") that is available when an alternate version of a drug (e.g., the dosage form change from injection to oral administration as tested within this Study) retains certain similar performance characteristics as an earlier-approved version of that same drug.

In both these respects, the results from this Study have shown tremendous promise while also evidencing tolerability advantages from a user appeal perspective.

Saxenda® is owned by Novo Nordisk, which also sells an oral tablet form of the blockbuster GLP-1 drug semaglutide under the brand name Rybelsus^®. Of note, the salcaprozate sodium ("SNAC") delivery technology that Novo Nordisk acquired for $1.8 billion utilized within the Rybelsus^® tablet was found by other researchers to be unfavorable for co-formulation of an oral version of liraglutide. Liraglutide went off patent in 2024 and is now offered in a generic injectable format by Teva Pharmaceuticals and others.

For these reasons, Lexaria is excited about the possibility of establishing DehydraTECH-liraglutide as a brand-new oral liraglutide-dosing alternative to Saxenda^® and the other generic versions of injected liraglutide. Lexaria feels this is an unmet market need which DehydraTECH may empower.

Lexaria has had, and intends to continue, discussions with pharmaceutical companies regarding the possibility of collaborating in pursuing a 505(b)(2) Pathway to enable commercialization of an oral DHT-LIR product. Further details on prospective next steps in development of the DHT-LIR product candidate will be provided when available in due course.

About the Study

Study GLP-1-H25-5 was a pilot, cross-over investigation in 10 overweight (average weight 73 Kg; average body mass index 26.81) volunteers. SAX-LIR injection was administered daily at its commercially available starting dose of 0.6 mg for 7 days with a follow-up evaluation at day 8, compared to oral DHT-LIR (45 mg), also administered daily for 7 days with an identical day 8 evaluation. All drug administrations were performed after an overnight fast. Oral administration was accomplished with a 50 mL glass of water. Blood draws were performed upon the subjects at baseline (pre-dose) and multiple time points over the first 12 hours of day 1 of the Study, followed by daily draws 30-minutes post-dosing on each of days 2-7 of the Study and, finally, on day 8 without any dosing. Subjects were allowed to consume standardized meals/snacks over the 12 hours post-dosing on the first treatment day at predetermined time intervals. Subjects were allowed to resume their normal diet following fasted dosing on the subsequent treatment days.

The DHT-LIR 45 mg dose equated to a 75-fold multiple of the 0.6 mg SAX-LIR dose exposure tested. This dosing multiple was selected conservatively relative to the 98- to 196-fold dosing multiple currently used with Novo Nordisk's Rybelsus^®-branded semaglutide, whereby a 14 mg Rybelsus^® daily dose is considered to be bioequivalent to a 0.5-1.0 mg once-weekly dose of its Ozempic^®- or Wegovy^®-branded semaglutide injectable products. Accordingly, Lexaria notes that there is arguably room to further titrate the DHT-LIR oral dose upwards in prospective future studies in an effort to most closely match the effectiveness of the injectable regimen consistent with its 505(b)(2) Pathway strategy.

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 60 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 intended use of proceeds from the offering and 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, market and other conditions, 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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