Lexaria Bioscience Corp., a global leader in drug delivery platforms, is nearing the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its upcoming U.S. Phase 1b Hypertension Clinical Trial. The company anticipates filing the application within the next 45 days.
This update follows a previous delay caused by waiting for essential documentation from a key raw material supplier. Lexaria is now pleased to report that the supplier has furnished most of the required documentation, both to Lexaria and directly to the FDA. This development allows Lexaria to finalize its IND application. The supplier has indicated that it will submit the final pieces of information to the FDA within the same 45-day timeframe, enabling Lexaria to proceed with its application submission.
Lexaria is confident in the safety of its proposed Phase 1b study, based on its track record of conducting five human clinical trials from 2018 to 2022. These studies involved DehydraTECH-CBD and encompassed a total of 134 participants, with no serious adverse events reported. The company eagerly anticipates the IND filing and subsequent 30-day review period by the FDA.
Background and Medical/Market Rationale
The previous studies, although not under FDA-registration, are crucial to the success of Lexaria's IND submission. Conducted with both healthy and hypertensive participants, these studies demonstrated significant reductions in resting blood pressure over various dosing regimens. Notably, no serious adverse events were reported. This evidence positions DehydraTECH-CBD as a potentially superior alternative to existing anti-hypertensive therapeutics.
Comparatively, other research in this field, primarily involving young, healthy, and normotensive volunteers, has not shown success in achieving sustained decreases in resting blood pressure through oral CBD dosing over multiple weeks. DehydraTECH-CBD, however, has shown unique effectiveness in reducing blood pressure compared to other oral CBD formulations.
Findings from Lexaria's recent study, HYPER-H21-4, revealed a potentially novel mechanism of action for DehydraTECH-CBD in reducing blood pressure. This may involve interaction with the human sympatho-chromaffin system through catestatin modulation, as detailed in the "Biomedicine and Pharmacotherapy" journal. This is particularly relevant as the FDA has outlined the need for new anti-hypertensive drugs with novel and complementary modes of action. Data from HYPER-H21-4 suggest DehydraTECH-CBD could offer additional blood pressure reduction benefits alongside standard care medications.
About Planned Clinical Trial HYPER-H23-1
Clinical trial HYPER-H23-1, titled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension’, aims to evaluate the safety and tolerability of DehydraTECH-CBD in hypertensive patients. Secondary objectives include efficacy evaluation in reducing blood pressure and detailed pharmacokinetic testing. All procedures for this study will be conducted entirely by U.S.-based independent service providers.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™, Lexaria’s patented drug delivery formulation and processing technology, enhances the bio-absorption of active pharmaceutical ingredients (APIs) through oral delivery. Since 2016, Lexaria has developed DehydraTECH for various molecules in oral and topical formats, demonstrating increased bio-absorption and effectiveness in crossing the blood-brain barrier. This is particularly significant for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a substantial intellectual property portfolio with 37 patents granted and many pending globally. For more information, visit www.lexariabioscience.com.
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