Lexaria's Oral Liraglutide Shows Promise as First Pill Alternative to Injections

Lexaria Bioscience Corp. (Nasdaq: LEXX), a global innovator in drug delivery platforms, has announced compelling final results from its Human Pilot Study #5, which compared its oral DehydraTECH-liraglutide (DHT-LIR) capsules to the injected Saxenda® branded liraglutide (SAX-LIR). The study successfully met its primary endpoint of evaluating safety and tolerability, demonstrating that the oral formulation functioned comparably to the traditional injection while showing a 22.7% reduction in adverse events, including a significant 67% reduction in nausea. CEO Richard Christopher emphasized that these results support the company's pursuit of the world's first oral liraglutide product through an expedited FDA regulatory development pathway known as a 505(b)(2) new drug application, which could revolutionize treatment options for patients.

The study revealed remarkable similarities in functional outcomes between the two delivery methods, with weight loss experienced by 9 out of 10 participants in each group despite the conservative 45 mg oral dose being a 75-fold multiple of the 0.6 mg injected dose. While pharmacokinetic testing faced challenges due to background signal noise from liraglutide binding with albumin in blood plasma, exploratory visualization showed broadly similar temporal patterns between treatments. This functional comparability is particularly noteworthy given that Lexaria's DehydraTECH technology appears to overcome limitations that other researchers found with alternative delivery systems, such as the SNAC technology used in Novo Nordisk's Rybelsus® tablet, which was found by other researchers to be unfavorable for co-formulation of an oral version of liraglutide.

With liraglutide now off patent and available in generic injectable formats from companies like Teva Pharmaceuticals, Lexaria sees a significant market opportunity for an oral alternative to Saxenda® and other injected versions. The company has been engaging in discussions with pharmaceutical partners about pursuing the 505(b)(2) Pathway for commercialization and plans to provide further details on development next steps. This breakthrough represents a potential paradigm shift in GLP-1 drug administration, offering patients a more convenient, potentially better-tolerated treatment option that could improve medication adherence and quality of life for those managing conditions like obesity and type 2 diabetes.