Ethics Review Approval for Lexaria’s GLP-1 Study

Lexaria Bioscience (Nasdaq: LEXX) has received approval from an independent third-party ethics review board for its human pilot study #2 investigating GLP-1 drugs in combination with Lexaria’s DehydraTECH technology. Lexaria will begin recruiting subjects for the study immediately, and expects to dose the first patient within 30 days. The company’s share price rose more than 16% in intraday trading following the news.

The study will be performed in up to nine 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®.

The second arm of the study will investigate an oral dissolvable tablet formulation, also compliant with the FDA IID, with DehydraTECH-powered semaglutide from Ryblesus®.

Commenting on the study, Chris Bunka, CEO of Lexaria, said, “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.”

GLP-1 drugs are well-established medicines that have demonstrated long-term safety, but are linked to adverse gastrointestinal reactions including diarrhea, nausea, and vomiting. Between 5% and 10% of patients discontinue use of a GLP-1 due to these side effects, and a study of more than 10,000 patients found that 56% “prefer oral medication over injections”.

“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,” concluded Mr. Bunka.

Lexaria expects to complete the study mid-year.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 41 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

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Ethics Review Approval for Lexaria’s GLP-1 Study

Catie Corcoran

Biotech Editor