Lexaria’s DehydraTECH-CBD(TM) Enhances Performance Compared to Epidiolex(R) in Seizure Study Program - Seite 2

Lexaria is encouraged by these results from its first foray into the anti-seizure testing field. The results to-date demonstrate the performance of DehydraTECH-CBD to reduce or eliminate seizure activity in animals and to, in some cases, even surpass the performance of one of the world's leading anti-seizure medications, Epidiolex. Overall, DehydraTECH-CBD appeared to demonstrate effectiveness at lower doses and more rapidly than Epidiolex. Future work under consideration may include additional DehydraTECH-CBD formulation optimization to support more sustained activity for this therapeutic application, where numerous pharmaceutical strategies exist to achieve prolonged drug action when needed.

ABOUT THE STUDY PROGRAM

Additional work is underway in study program EPIL-A21-1 with a final MES study designed to establish an ED50 (i.e., the dose required to achieve seizure inhibition in 50% of the animals tested) for DehydraTECH-CBD in this animal model, where ED50 determination is a common performance metric in preclinical animal studies for developmental therapeutics. This ED50 study is designed to corroborate the MES experimental findings to-date, and Lexaria will provide further updates and any relevant material findings in due course from this study as they become available.

Study program EPIL-A21-1 was designed as a three-part series utilizing Sprague Dawley rats; 21 animals in the pilot study; 24 animals in time to peak efficacy study; and 24 animals in the ED50 study. In all three experiments, seizure activity was induced by the MES model methodology and treatment effect was judged by evaluation of acute clinical signs in the animals. Treatment timing relative to seizure induction following the MES model methodology was based upon published literature of the biological activity of the positive control, Epidiolex. Study program EPIL-A21-1 is being performed by a leading, US-based independent laboratory and is fully funded by Lexaria.

ABOUT THE SEIZURE MARKET OPPORTUNITY

Epidiolex/Epidyolex is one of the world's leading drugs used to combat certain forms of seizure disorders with other anti-seizure applications as well, generating revenue of $196.2 million in the most recent fiscal quarter for owner Jazz Pharmaceuticals. Cannabidiol is the active ingredient within Epidiolex. Epidiolex revenues grew by 22% from the same quarter last year, compared to roughly 2.5% to 4.5% growth for all epilepsy drugs as a whole.