Lexaria Bioscience (LLX.C) announced today that treatment and dosing in its human clinical study, HYPER-H21-1, have been completed ahead of schedule.
“Completing this work in the midst of the COVID-19 pandemic was challenging and we acknowledge and commend the dedication and work ethic of our Europe-based research partners and all parties involved…Blood samples from the study volunteers will be shipped this week to our U.S. and Canadian analytical testing laboratory partners, and we expect to complete all sample and data analyses and reporting ahead of schedule, by July or August instead of the end of Q3 as previously indicated,” stated Chris Bunka, CEO of Lexaria.
Lexaria’s HYPER-H21-1 human clinical study is intended to test the efficacy of the Company’s DehydraTECH™-enabled cannabidiol (CBD) for potential use as a hypertension treatment alternative. DehydraTECH™ refers to Lexaria’s proprietary drug delivery technology, focused on improving the way active pharmaceutical ingredients (APIs) enter the bloodstream. The Company’s drug delivery technology can be applied to a variety of ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. Since 2016, Lexaria’s DehydraTECH™ has demonstrated superior bio-absorption of nicotine and cannabinoids as well as greatly improved onset times. Compared to convention absorption methods, which can take up to 1 to 2 hours, DehydraTECH™ was able to reduce time of onset to mere minutes.
With this in mind, Lexaria’s HYPER-H21-1 study was comprised of twenty-four human volunteers aged 45 to 65 who were then dosed DehydraTECH™-enabled CBD. All volunteers tolerated treatment well with no serious side effects observed or reported. Evaluation of time series blood pressure and heart rate analyses were the primary objectives of this study. Lexaria’s second human clinical study, HYPER-H21-2, is set to begin immediately and will include sixteen human volunteers. The Company expects that all dosing visits in this study should be completed around July. Lexaria is hopeful that all sample and data analyses will be completed in late September.
In addition to hypertension, DehydraTECH™ has shown potential in treating COVID-19 when processed with remdesivir and ebastine. Remdesivir and ebastine are antiviral and antihistamine medications, respectively. When processed with Lexaria’s DehydraTECH™, both proved effective at inhibiting the COVID-19 SARS-CoV-2 virus during the Company’s VIRAL-C21-3 study. Lexaria’s antiviral study program may also have benefits beyond COVID-19, including a wide range of other viral disease indications where improved oral delivery is needed. With this in mind, DehydraTECH™ is shaping up to be an adaptable formulation.
Lexaria’s share price opened at $8.17, down from a previous close of $8.25. The Company’s shares are down 0.61% and are currently trading at $8.20 as of 10:40AM ET. This indicates that there has been some change following the news.
