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- Lexaria, a global innovator in drug delivery platforms, has received approval for its GLP-1 human pilot study #2 by an independent third-party ethics review board
- GLP-1 drugs are utilized in the treatment of type 2 diabetes and obesity, a huge market, and are typically administered by painful and expensive injection, offering a major opportunity for Lexaria’s oral delivery platform
- This approval sets the company up for dosing within 30 days or less, with tentative study completion dates for this summer
- The study will comprise two study arms, the second study arm will investigate whether Lexaria’s patented DehydraTECH(TM)-enhanced semaglutide can effectively absorb into the sublingual/buccal tissues of the mouth with fewer side effects
- For Lexaria, this milestone brings it closer to its objective of forging strategic partnerships with leading industry players, ultimately growing shareholder value
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced approval for its GLP-1 human pilot study #2 by an independent third-party ethics review board. The potential use of Lexaria’s oral delivery platform for GLP-1 drugs, typically administered by injection or stomach-upsetting tablets, represents a massive market opportunity. This study approval marks a milestone for the company, with the first dosing set to begin within 30 days or less, and with tentative completion dates for this summer (https://cnw.fm/QDjNj).
The human pilot study will seek to explore Lexaria’s patented DehydraTECH(TM) technology and its overall effectiveness in the delivery of glucagon-like peptide-1 (“GLP-1”). It will involve up to 9 healthy volunteers and feature two study arms, each evaluating tolerability, blood absorption levels, and blood sugar control.
The first study arm will use a Rybelsus(R) composition processed with DehydraTECH and delivered within swallowed capsules. The second arm will explore an oral dissolvable tablet formulation with DehydraTECH-powered semaglutide from Rybelsus(R). This will mark the very first study design 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 adequate level of blood absorption.
Earlier in March, Lexaria announced having hired a contract research organization (“CRO”) to perform this specific study, described as a randomized, crossover, placebo-controlled investigation (https://cnw.fm/fq3mr). This ethics review board approval is a testament to the steady progress of the company. It also allows Lexaria to maintain its current momentum by meeting the study objectives and realizing the timelines set out at the beginning of the year. More importantly, these milestones inch the company closer to forging strategic partnerships with leading industry players, which would be integral in growing shareholder value.
“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,” noted Chris Bunka, Lexaria’s CEO.
“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,” he added.
Previous studies have demonstrated DehydraTECH’s ability to improve the delivery of certain drugs destined for the bloodstream. Lexaria hopes to replicate these results in this study to usher in a new era in GLP-1 delivery without the need for painful injections or stomach-upsetting tablets. Its management is optimistic about the study results, and the ethics review board approval brings the company closer to realizing this objective.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX
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