Lexaria Bioscience Corp. (NASDAQ:LEXX) ("Lexaria" or the "Company"), a global innovator in oral drug delivery platforms, provides this update on Human Pilot Study #7 (GLP-1-H26-7) that will evaluate two oral DehydraTECH-semaglutide ("DHT-sema") compositions against Novo Nordisk's® commercially available Wegovy® tablets (the "Study").
Submissions have now been entered to formally request the required ethics approval from an independent review board. Final laboratory tablet composition work and commercial-scale manufacturing for the DHT-sema test articles for the Study have been completed with third-party independent lab quality-control ("QC") testing of such test articles currently underway. It is anticipated that receipt of ethics approval, completion of QC testing and packaging of the qualified test articles (the "Pre-Dosing Tasks") will occur by early June.
The design of this Study is complete, subject to any modifications which may or may not be required by the ethics reviewers. The Study is planned to be a five-week parallel group design, investigating three separate arms to assess safety & tolerability and pharmacokinetic ("PK") properties that will compare salcaprozate sodium ("SNAC")-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy® tablets. The Study will be conducted under fasted pre-dose conditions. Lexaria hopes to preserve the superior safety and tolerability profiles as evidenced in previous Lexaria GLP-1 studies such as Human Study #4 (GLP-1-H25-4), combined with PK performance that matches or exceeds that of the commercial oral tablet as also evidenced in previous Lexaria SNAC-inclusive DHT-sema studies such as Human Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2; which, incidentally, also evidenced noteworthy safety and tolerability profiles).
The results of this Study are expected to be carefully reviewed by the pharmaceutical industry in order to evaluate the possibility of entering into commercial relationships focused on Lexaria's proprietary DehydraTECH technology.
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