- Lexaria, a global innovator in drug delivery platforms, recently received FDA clearance for its HYPER-H23-1 clinical study
- John Docherty, President of Lexaria, has regarded this milestone as a demonstration of its patented DehydraTECH(TM) technology’s overall viability, particularly in the potential treatment of hypertension
- With HYPER-H23-1, Lexaria looks to build on the success of its previous human clinical studies, whose results have been overwhelmingly positive
- This marks a considerable milestone even as the company looks to double down on GLP-1 studies for the 2024 calendar year
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, just announced that the U.S. Food and Drug Administration (“FDA”) has given it the requisite clearance to proceed with its planned U.S. Phase 1b hypertension clinical trial. This follows the company’s Investigational New Drug (“IND”) application earlier in the year.
The HYPER-H23-1 clinical trial, entitled “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 seek to explore the overall effectiveness of its patented DehydraTECH(TM)-processed CBD for the potential treatment of hypertension. The primary objective will be to evaluate the safety and tolerability in hypertensive patients, with secondary objectives including efficacy evaluation in reducing blood pressure and detailed pharmacokinetic testing (https://ibn.fm/ch6DA).
According to John Docherty, President of Lexaria, this clearance by the FDA demonstrates its technology’s overall potential, having met the FDA’s high level of regulatory scrutiny.
“This is a significant milestone achievement for Lexaria demonstrating, for the first time, that its DehydraTECH technology meets the FDA’s high level of regulatory scrutiny sufficient to formally commence U.S. registrational clinical testing towards possible future pharmaceutical commercialization,” noted Mr. Docherty.
Since 2018, Lexaria has conducted five human clinical studies for its DehydraTECH-CBD on 134 healthy, normal, and hypertensive volunteers. The results have been overwhelmingly positive, evidencing reductions in resting blood pressure over both acute and multi-week dosing regimens. The studies also produced zero serious adverse events, pointing to DehydraTECH’s potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.
With HYPER-H23-1, Lexaria looks to build on the success of its previous studies, ultimately asserting the superiority of its technology, while also inching closer to tapping into the hypertension treatment market, which was valued at $31.76 billion in 2022, and is expected to reach $43.18 billion by 2030 (https://ibn.fm/Uror5).
“We look forward to commencing this important clinical trial and building upon the wealth of early-stage clinical data we have gathered and presented to the FDA to date demonstrating the safety, efficacy, and novel mechanistic performance of DehydraTECH-CBD in hypertensive patients,” noted Mr. Docherty.
This is a huge milestone for Lexaria and its team, especially following the plans to commence with its diabetes and weight loss animal study, coupled with doubling down on its GLP-1 clinical studies for the 2024 calendar year. All these steps reflect the company’s commitment to creating shareholder value and further developing its DehydraTECH technology, which has the potential to be a leader in its space.
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://ibn.fm/LEXX
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