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

Rhea-AI Summary

Lexaria Bioscience (NASDAQ: LEXX) has successfully completed a human clinical study comparing oral DehydraTECH-liraglutide capsules to injectable Saxenda (liraglutide). The study demonstrated a 22.7% overall reduction in adverse events with the oral formulation, including significant decreases in nausea (67%) and gastrointestinal issues (31%). The oral version showed comparable effectiveness in blood glucose, insulin, and weight loss metrics. This breakthrough positions Lexaria to pursue FDA registration through the 505(b)(2) pathway for an oral alternative to injectable liraglutide, which generated $1.8B in revenue for Novo Nordisk in 2024. Notably, Lexaria has now shown reduced adverse events with DehydraTECH versions of all three major GLP-1 drugs: liraglutide, semaglutide, and tirzepatide.

Positive

• Clinical study showed 22.7% reduction in adverse events with oral DehydraTECH-liraglutide compared to injectable Saxenda
• Significant reductions in key side effects: 67% decrease in nausea and 31% reduction in gastrointestinal adverse events
• Comparable effectiveness in blood glucose, insulin, and weight loss metrics to injectable version
• Potential for expedited FDA approval through 505(b)(2) pathway
• Large market opportunity with liraglutide generating $1.8B in revenue for Novo Nordisk in 2024

Negative

• Weight loss slightly lower in DehydraTECH-liraglutide compared to Saxenda
• Only partial results are currently available from the study
• Partnership with pharmaceutical company still needed for FDA registration

Insights

Pharmaceutical Industry Analyst

Lexaria's oral GLP-1 delivery shows fewer side effects than injectable liraglutide, potentially creating valuable licensing opportunity.

Lexaria's human clinical study results demonstrate that their DehydraTECH platform can deliver liraglutide orally with 22.7% fewer adverse events compared to Novo Nordisk's injectable Saxenda®. Most impressively, their oral formulation reduced nausea by 67% and gastrointestinal adverse events by 31% - addressing major tolerability issues that plague GLP-1 medications.

The study showed comparable efficacy metrics for blood glucose, insulin, and weight loss effects between oral DehydraTECH-liraglutide and injectable Saxenda®. This similarity is crucial as it potentially enables Lexaria to pursue FDA approval through the expedited 505(b)(2) pathway, which allows for approval based on prior safety/efficacy data when a new formulation maintains similar pharmacological properties.

What makes this particularly intriguing is that Lexaria has now demonstrated reduced adverse events with all three major GLP-1 drugs (liraglutide, semaglutide, and tirzepatide) using their technology. With liraglutide now genericized after patent expiration, Lexaria is positioned to seek pharmaceutical partnerships to commercialize an oral alternative to injectables.

This timing aligns perfectly with market conditions - despite generic competition from Teva, Novo Nordisk still generated $1.8 billion from liraglutide products in 2024. Notably, Novo's own oral delivery technology (SNAC), which they acquired for $1.8 billion and use in Rybelsus®, has been deemed unsuitable for liraglutide formulation by researchers.

By potentially solving the oral delivery challenge for liraglutide when Novo Nordisk's own technology couldn't, Lexaria may have created significant licensing value. A pharmaceutical partner could leverage DehydraTECH to create a differentiated product in the increasingly competitive GLP-1 market where patient preference for oral administration remains strong.

• 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
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 ACCESS Newswire

FAQ

What are the key findings of Lexaria's DehydraTECH-liraglutide clinical study?

The study showed a 22.7% reduction in adverse events compared to injectable Saxenda, with 67% less nausea and 31% fewer gastrointestinal issues, while maintaining comparable effectiveness in blood glucose and insulin metrics.

How does LEXX's oral liraglutide compare to injectable Saxenda for weight loss?

While 9 out of 10 participants in both groups experienced weight loss, the Saxenda injectable group showed slightly higher weight loss, though this wasn't a primary study endpoint due to the short treatment period.

What is the market potential for Lexaria's oral liraglutide formulation?

The market potential is significant, as injectable liraglutide generated $1.8 billion in revenue for Novo Nordisk in 2024 through Saxenda and Victoza brands, despite generic competition.

What is the regulatory pathway for LEXX's DehydraTECH-liraglutide?

Lexaria plans to pursue FDA registration through the 505(b)(2) pathway, which can be expedited when an alternate version of an approved drug shows similar performance characteristics.

How does DehydraTECH technology differ from existing oral GLP-1 delivery methods?

Unlike the SNAC technology used in Rybelsus, which was found unfavorable for oral liraglutide, DehydraTECH has demonstrated successful oral delivery with reduced adverse events across all three major GLP-1 drugs.