Positive results in recent animal study strongly support first-ever human investigation for DehydraTECH-liraglutide
KELOWNA, BC / ACCESSWIRE / December 9, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to announce the engagement of a contract research organization (“CRO”) to design and execute a human pilot study evaluating DehydraTECH-liraglutide against Saxenda® injectable liraglutide.
As reported on November 20th in Lexaria’s 12-week rodent study with unlimited food available, DehydraTECH-processed liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline. The Rybelsus® (semaglutide) control, which was expected to outperform liraglutide, instead produced a 5.65% increase in body weight and 0.41% blood sugar reduction compared to baseline during the same 12 weeks.
As a result of the stronger than expected performance of DehydraTECH-processed liraglutide, the Company has made the decision to investigate further with human study GLP-1-H25-5 expected to be conducted with 8-10 healthy volunteers (the “Study”). The goal of the Study will be to demonstrate safety and test pharmacokinetic performance in humans with an oral version of DehydraTECH-processed liraglutide. If positive, it could support a future decision to investigate DehydraTECH-liraglutide in a future Phase I registered trial.
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 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.
“Liraglutide is a multi-billion dollar annual market-size opportunity,” said Richard Christopher, CEO of Lexaria. “Several months ago, the US FDA authorized the first generic version of liraglutide, and Lexaria feels that if we are able to demonstrate similar, or superior, delivery of liraglutide via an oral capsule or tablet, we could provoke additional new revenue opportunities for this important GLP-1 drug.”
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.
Development of the Study protocol is underway and Lexaria and the CRO are evaluating options for selection of the clinical site and jurisdiction in which to perform this Study, which has not yet been determined. Further updates will be provided in due course when Lexaria has obtained the necessary ethics board approval before the Study can begin.
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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INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
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