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Human Pilot Study #2 (GLP-1-H24-2) Approved
KELOWNA, BC / ACCESSWIRE / April 16, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces approval has been received from an independent third-party ethics review board, for human pilot study #2 (the "Study"), investigating GLP-1 drugs and DehydraTECH.
Subject recruitment will begin immediately and the Company will announce as soon as the first dosing has begun, expected within 30 days or less. The Company anticipates completing the Study this summer.
The Study will be performed in up to 9 healthy volunteers and will study a single 7 mg dose of Rybelsus® (semaglutide) against two different, concentration-matched 7 mg DehydraTECH-enabled semaglutide formulations from crushed Rybelsus®.
One DehydraTECH Study arm will use a Rybelsus® composition processed with DehydraTECH that is compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database ("FDA IID"), delivered within swallowed capsules. This arm will be otherwise similar to the first DehydraTECH GLP-1 human pilot study conducted that evidenced higher delivery of semaglutide into blood with superior blood glucose control and better tolerability than was achieved with Rybelsus®.
The second DehydraTECH Study arm will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH powered semaglutide from Ryblesus®. This will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can effectively absorb into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed administration, and with some effective level of blood absorption.
Tolerability, blood absorption levels (pharmacokinetics or "PK"), and blood sugar control will all be evaluated. The DehydraTECH compositions for this study will be compound-formulated using commercially available Rybelsus® tablets as the semaglutide input material.
"I am excited about this Study; the Lexaria scientific team believes that a dissolvable oral tablet that delivers an effective fraction of semaglutide along with reduced side effects could potentially offer valuable benefits to the pharmaceutical industry that might lead to a higher likelihood of favorable strategic partnering with leading industry players in GLP-1," said Chris Bunka, CEO of Lexaria. "Most GLP-1 drugs sold today are administered by painful and expensive injection devices. More effective and tolerable oral delivery of GLP-1 drugs could be extremely valuable to patients and to industry."
