Lexaria Bioscience Corp. (NASDAQ:LEXX) ("Lexaria" or the "Company"), a global innovator in oral drug delivery platforms, is pleased to announce that ethics approval has been received from an independent review board, for 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").
"Lexaria is delighted to have received the independent ethics review board approval so quickly," said Richard Christopher, CEO of Lexaria Bioscience. "Lexaria is looking for this Study to provide the positive outcomes necessary to support commercial collaboration within the pharmaceutical industry related to Lexaria's demonstrated improvements in delivering oral GLP-1 drugs in real-world environments."
Lexaria is seeking to preserve the superior safety and tolerability profiles evidenced in its previous glucagon-like peptide-1 ("GLP-1") studies such as Human Study #4 (GLP-1-H25-4), combined with pharmacokinetic ("PK") performance that matches or exceeds the Wegovy® tablet control over a 5-week period. Previous Lexaria salcaprozate sodium ("SNAC")-inclusive DHT-sema single dose studies such as Human Pilot Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2) evidenced PK performance that matched or exceeded the Rybelsus® control arm and 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.
Laboratory tablet composition work and commercial-scale manufacturing for the DHT-sema test articles for the Study have been performed. Third-party independent lab quality-control ("QC") testing of those test articles is currently underway and is expected to be complete in early June. Packaging of all the test articles suitable for the Study will be undertaken in parallel with this.
The design of the Study is now complete: a five-week parallel group design, investigating three separate arms to assess safety & tolerability and PK properties that will compare SNAC-inclusive DHT-sema tablet and capsule formulations to commercially available Wegovy® tablets. The Study will be conducted under fasted pre-dose conditions.
The Study explores several new DehydraTECH enhancements not previously evaluated, which include but are not limited to the following two main improvements:
(1) First, an oral tablet DHT-sema composition will be used by Lexaria for the first time, as opposed to only the capsule compositions included in all our previous DHT GLP-1 studies. Novo Nordisk's® Rybelsus® and Wegovy® oral semaglutide medications both use specially formulated tablets designed to temporarily adhere to the stomach lining and disintegrate and dissolve releasing agents in a focal manner that aids in optimizing absorption of the active ingredient - semaglutide - into the human body. For the first time ever, Lexaria has attempted to mimic and integrate certain properties of the Rybelsus®/Wegovy® SNAC-inclusive tablet delivery modality into its DHT-sema tablets to increase the likelihood of subsequent commercial pharmaceutical relationships.
(2) Second, both the Lexaria DHT-sema tablet and capsule test articles will be formulated with SNAC, which will be the first time these formulations are evaluated over a multi-dose, multi-week time period in humans. The five-week dosing duration of the Study is expected to be long enough to reach so-called steady-state, which is when drug concentrations in the body reach a constant concentration. As noted above, Human Pilot Studies #1 and #2 (GLP-1-H24-1 and GLP-1-H24-2), conducted in 2024 and 2025 which incorporated SNAC (but did not use tablets), were limited by single-dose study designs; therefore, of much shorter duration.
Lexaria currently expects dosing to begin in mid-June. The Study is fully funded from existing corporate resources.