- Lexaria, a global innovator in drug delivery platforms, has announced the successful completion of its second round of dosing for its human pilot study #2
- The final study arm is set for completion in early July, and if successful, it will help remedy the downsides of swallowed administration
- The study’s main objective is to evaluate Lexaria’s patented DehydraTECH(TM) technology for the oral delivery of the glucagon-like peptide-1 (“GLP-1”) drug, semaglutide, currently commercially available as Rybelsus(R)
- The commencement of the pilot study shows Lexaria’s commitment to its promise to focus on GLP-1 studies for 2024, along with its confidence in its DehydraTECH technology
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has announced the successful completion of its second round of dosing for its human pilot study #2, GLP-1-H24-2. The study aims to evaluate the company’s patented DehydraTECH(TM) technology for the oral delivery of the glucagon-like peptide-1 (“GLP-1) drug semaglutide, which is currently commercially available in the branded product Rybelsus(R) (https://ibn.fm/5GcOz).
This second round of dosing utilized Rybelsus processed with DehydraTECH and is compliant with the U.S. Food and Drug Administration’s Inactive Ingredient Database (“FDA IID”), which was administered with swallowed capsules. All nine study participants were successfully dosed, building on the initial study arm, which used a positive control Rybelsus swallowed tablet, whereas the third arm will explore an in-mouth dissolvable DehydraTECH-semaglutide oral tablet.
This third and final study arm will be the first study designed to investigate whether DehydraTECH-enhanced semaglutide can be absorbed into the bloodstream at any level systemically into the sublingual/buccal tissues of the mouth and throat with fewer side effects than from swallowed pill administration. This study is set to be completed in early July. If successful, this study will help remedy the downsides of swallowed administration, which is heavily impacted by the stomach’s acidic environment. This environment significantly degrades GLP-1 drugs swallowed, resulting in meager blood absorption rates of less than 1% when absorption technology is not used.
This move aligns with Lexaria’s plan to focus on GLP-1 studies for the 2024 calendar year. It also speaks to its commitment and overall confidence in the potential of its DehydraTECH technology. It is an important milestone for the company, mainly since, at the very beginning, the GLP-1 studies were considered a “high-risk” program, according to its CEO, Chris Bunka. This was mainly attributed to the fact that the study fell under a class of drugs considered “large molecules,” a class that the company had never explored before, especially given its focus on “small molecules” (https://ibn.fm/275ZI).
So far, Lexaria has achieved great success with its GLP-1 studies. In addition, the rising interest in GLP-1 drugs, owing to their health benefits, has seen the company double down on this research going forward. The successful completion of the second round of dosing for its GLP-H24-2 human pilot study indicates this commitment while ushering in what’s to come for the company.
For more information, visit the company’s website at www.LexariaBioscience.com.
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