Lexaria's Human GLP-1 Study #5 Receives Independent Review Board Approval
Positive results in a recent animal study strongly supports first-ever human investigation for DehydraTECH-liraglutide in an oral capsule format
KELOWNA, BC / ACCESSWIRE / January 15, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that it has received the necessary independent ethics board approval required for its contract research organization ("CRO") to begin to implement and execute human pilot study GLP-1-H25-5 (the "Study"). The Study will compare an oral version of liraglutide, formulated from the DehydraTECH-processing of Saxenda® ("DehydraTECH-liraglutide") to the conventional injected liraglutide (Saxenda®).
Lexaria has already demonstrated success in DehydraTECH processing for superior human oral delivery performance of the world's two most widely used GLP-1 drugs; semaglutide (Novo Nordisk®) and tirzepatide (Eli Lilly). Liraglutide, also owned by Novo Nordisk®, is the world's 3rd most popular glucagon-like peptide-1 ("GLP-1") or glucose-dependent insulinotropic ("GIP") weight loss/diabetes drug on the market today. Lexaria has previously investigated liraglutide in a 12-week rodent study, as reported on November 20, 2024, in which DehydraTECH- liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline, outperforming the comparably dosed positive control semaglutide product, Rybelsus®, also tested in that study.
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 injected version of liraglutide by Teva® during 2024, liraglutide sold by Novo Nordisk® under the brand name of Saxenda® still generated US$849 million in the first half of 2024; and under the brand name Victoza®, generated an additional US$1.6 billion in recent annual revenue.
The Study is expected to be conducted with 8-10 healthy volunteers with the goals of demonstrating safety and pharmacokinetic performance in humans utilizing orally dosed DehydraTECH-liraglutide. If the Study results are positive, it could support a decision to investigate oral DehydraTECH-liraglutide in a future Phase I registered trial.
"All three of the GLP-1 and GIP drugs that Lexaria has tested during the last fifteen months have delivered successful results," said Richard Christopher, CEO of Lexaria. "We are establishing our technology as perhaps the most effective drug delivery technology in the world to date, for weight loss drugs such as GLP-1."
Approved for use by diabetics to control blood sugar, liraglutide has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly 50% as compared to placebo.
The Study protocol design is complete and a clinical test site has been determined. Further updates will be provided when the first dosing begins.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to 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 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
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SOURCE: Lexaria Bioscience Corp.
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