- Lexaria just announced the completion of batch manufacturing of its patented DehydraTECH(TM)-processed CBD and placebo materials for its FDA Phase 1b HYPER-H23-1 human clinical study
- This is in line with the company’s IND filing with the FDA, which it looks to complete this summer, with potential authorization within 60 days
- FDA authorization will mark the commencement of Phase 1b trial patient dosing, with the study evaluating the safety and tolerability of DehydraTECH-CBD in hypertensive patients
- Filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, announced an ambitious plan to embark on its Food and Drug Administration (“FDA”)-registered, U.S. Phase 1b Investigational New Drug (“IND”) hypertension study, HYER-H23-1. Earlier in May, the company announced the awarding of the contract for clinical research organization (“CRO”) services to California-based InClin, Inc. Since this announcement, it has completed batch manufacturing of its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) and placebo materials for the study (https://cnw.fm/MR9kR).
Lexaria retained the services of a U.S. contract manufacturing organization to produce these study materials, in line with current Good Manufacturing Practice (“cGMP”) regulations as directed by the FDA. With everything on track, the company looks to file the IND this summer, with potential authorization by the FDA within 60 days in what will mark the commencement of Phase 1b trial patient dosing, possibly in October 2023.
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,” Hyper-H23-1 will explore the safety and tolerability of its DehydraTECH-CBD in hypertensive patients. It will also monitor the efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing, building on the five previous human clinical studies which evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens with zero serious adverse events.
The filling into capsules of the manufactured DehydraTECH-CBD is expected to be completed before the end of this month, after which analytical release and stability testing will be conducted to gather essential quality control data essential for the IND filing. So far, DehydraTECH-CBD has shown the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics. In addition, none of the other published studies thus far have shown a sustained decrease in resting blood pressure following multiple weeks of oral CBD dosing, demonstrating DehydraTECH-CBD’s superior power to reduce blood pressure over other oral CBD formulations.
Finalized DehydraTECH-CBD batch manufacturing marks a significant step towards IND filing and subsequent FDA approval for Lexaria. It also marks a notable achievement for the company, especially given the multiple human clinical studies conducted since 2018 and the over 130 healthy and hypertensive persons that have taken part in the studies so far. Its management is optimistic about the HYPER-H23-1 clinical study and is confident that results from the company’s previous efforts will be replicated, if not exceeded.
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
CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.
To receive instant SMS alerts, text CANNABIS to 21000 (U.S. Mobile Phones Only)
For more information please visit https://www.cannabisnewswire.com
Do you have questions or are you interested in working with CNW? Ask our Editor
CannabisNewsWire is part of the InvestorBrandNetwork.