- Lexaria, a global innovator in drug delivery platforms, expects to submit its IND application for its planned U.S. Phase 1b Hypertension Clinical Trial with the FDA within the next 45 days
- The HYPER-H23-1 clinical study will build on five successful human clinical trials conducted so far, studying the company’s patented DehydraTECH(TM)-processed CBD in an aggregate total of 134 individuals
- Lexaria’s patented DehydraTECH(TM) “drug delivery platform technology” increases bioavailability, improving the way active pharmaceutical ingredients (“APIs”) enter the bloodstream
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced that it anticipates submitting its Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration within the next 45 days. The submission will be for its U.S. Phase 1b Hypertension Clinical Trial, whose primary objective will be to evaluate safety and tolerability in hypertensive patients, with secondary objectives including efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing (https://cnw.fm/8E4Rg).
The HYPER-H23-1 clinical study, 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” will explore Lexaria’s patented DehydraTECH(TM) technology, specifically its DehydraTECH-processed CBD for the potential treatment of hypertension. It will be a successful build-up from five human clinical trials conducted so far, studying DehydraTECH-CBD in an aggregate total of 134 individuals. Its management is optimistic that these previous studies will contribute to the success of the current one while allowing for the IND review process to run smoothly.
Only a handful of other published research studies have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this.. All of the company’s clinical studies showed that DehydraTECH-CBD achieved a sustained decrease in resting blood pressure following multiple weeks of oral dosing. In addition, DehydraTECH-CBD has evidenced superior power to reduce blood pressure, especially compared to other oral CBD formulations. DehydraTECH-CBD has also shown the potential to offer additive blood pressure reduction benefits in addition to any degree of improvement that standard-of-care medications achieved for patients prior to DehydraTECH-CBD dosing, ultimately showing the product’s superiority, overall efficiency, and potential.
Despite having encountered delays before, mainly owing to awaited documentation from one of its key raw material suppliers, Lexaria’s management is excited to submit its IND. Should it be approved, Lexaria will enjoy increased market opportunity for its DehydraTECH technology, specifically its DehydraTECH-CBD. In addition, it will get the company closer to tapping into the cardiovascular drugs market, valued at $138.33 billion in 2022 and expected to hit $200.9 billion by 2032 (https://cnw.fm/D3Ipo).
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX
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