Lexaria's DehydraTECH-Liraglutide Human GLP-1 Clinical Study Supports Pathway to Potential FDA Registration as an Orally-Delivered Capsule

• Oral DehydraTECH-liraglutide showed a pronounced reduction in adverse events (“AEs”) as compared to injected liraglutide (Saxenda(R)) 

• Lexaria has now demonstrated, in distinct human clinical studies, clear reductions in AEs utilizing its patented DehydraTECH technology with all of the three major GLP-1 drugs sold in the world today: liraglutide, semaglutide and tirzepatide 

KELOWNA, BC / ACCESS Newswire / June 11, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that human study GLP-1-H25-5 (the "Study") which compared oral capsules of DehydraTECH-liraglutide to injected Saxenda®-branded liraglutide has been successfully completed with partial results now available.

In distinct clinical human studies, Lexaria has now demonstrated clear reductions in AEs utilizing oral DehydraTECH versions of all three of the major GLP-1 drugs sold in the world today: liraglutide, semaglutide, and tirzepatide. For liraglutide specifically, which is currently sold in genericized versions due to patent expiration, Lexaria is now searching for a pharmaceutical partner interested in utilizing DehydraTECH to support an FDA-registered oral alternative to the current injectable brands within GLP-1.

There were a total of 23 AEs in the Saxenda® injected liraglutide study arm, as compared to 21 in DehydraTECH-liraglutide oral capsule arm. Of note, 4 of the AEs in the DehydraTECH-liraglutide oral capsule study arm were due to the placement of the peripheral intravenous line used for blood sampling necessary for purposes of conducting the study and, thus, unrelated to the drug treatment; whereas only 1 such AE was recorded in the Saxenda® injected liraglutide study arm. With those AEs removed from the analysis, oral DehydraTECH-liraglutide offered a 22.7% reduction in AEs as compared to the injected Saxenda®.

Particularly noteworthy were the reductions by 67% with respect to nausea and by 31% with respect to gastrointestinal AEs, utilizing oral DehydraTECH-liraglutide as compared to the injected Saxenda®.

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 relatively short treatment period. Evaluating the safety and tolerability of the DehydraTECH-liraglutide capsules relative to Saxenda® was the primary endpoint of this Study and this objective was successfully met with clear signs of improvement.

The two most important strategic objectives of this Study were:

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

2 - To demonstrate comparable functional results to the injected version, which if successful, could allow for an expedited FDA regulatory pathway known as a 505(b)(2) application 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, Lexaria feels that the partially completed results from this Study have shown tremendous promise, while also evidencing tolerability advantages from a user appeal perspective.

Saxenda® is owned by Novo Nordisk, who 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 ("SNAC") was found by other researchers to be unfavourable for co-formulation of an oral version of liraglutide.

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.

Background
On November 20, 2024, Lexaria reported on an earlier 12-week study in rodents which demonstrated positive findings supportive of advancement to the human clinical Study described herein.

Lexaria has previously shown in other GLP-1 studies in humans, that certain oral DehydraTECH formulations demonstrated superior effectiveness and bloodstream delivery, as well as reduced AEs as compared to the oral semaglutide and injectable tirzepatide products on the market today.

Liraglutide is currently sold only in an injectable form under the brand names Saxenda® and Victoza®, both manufactured by Novo Nordisk. Despite the launch of a genericized version of liraglutide by Teva Pharmaceutical Industries, Ltd. in June of 2024, Novo Nordisk generated US$1.0 billion in Saxenda® revenue, as well as an additional US$0.8 billion in Victoza® revenue during 2024.

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. Saxenda® 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 DehydraTECH-liraglutide (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 DehydraTECH-liraglutide 45 mg dose equated to a 75-fold multiple of the 0.6 mg Saxenda® liraglutide 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, the only oral GLP-1 drug on the market today, whereby a 14 mg Rybelsus® daily dose is considered to be bioequivalent to a 0.5-1.0 mg once-weekly dose of their Ozempic® or Wegovy® branded semaglutide injectable products. Accordingly, Lexaria notes that there is arguably room to further titrate the DehydraTECH-liraglutide 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 application regulatory strategy.

The primary endpoint of the Study was evaluation of the safety and tolerability. Secondary and exploratory objectives included evaluations of pharmacokinetics ("PK") and pharmacodynamic parameters including effects upon body weight, blood glucose and blood insulin levels. Results from the PK component of the Study are still being analyzed and will be reported upon once available.

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 48 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
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INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.