- Lexaria, a global innovator of drug delivery platforms, recently filed a pre-IND meeting request letter with the FDA, initiating communication regarding the development of its DehydraTECH-CBD as a treatment for hypertension
- The company has been undertaking preparatory programs in readiness for the meeting, as well as an IND application filing
- The pre-IND meeting will confirm the details of the company’s IND-enabling program
- Lexaria also announced it had licensed its DehydraTECH technology to AnodGen, with the announcement following similar out-licensing agreements with Valcon Medical and Premier Science
Early last September, global innovator Lexaria Bioscience (NASDAQ: LEXX) was pleased to announce it had formally commenced the process toward an Investigational New Drug (“IND”) application filing with the Food and Drug Administration (“FDA”) with its DehydraTECH(TM)-processed cannabidiol (“CBD”) for the treatment of hypertension (https://ibn.fm/WQFnA).
According to the September 8 news release, Lexaria had retained the services of an expert regulatory affairs and quality assurance consulting group that would help prepare the company for a pre-IND meeting with the FDA. The group would also assist Lexaria with designing the requisite non-clinical, clinical, and related product development IND-enabling work/program meant to be finalized before the company files its IND application.
Through the intervening period, Lexaria has made progress bringing it closer to achieving these goals, recently reporting it had filed a pre-IND meeting request letter with the FDA. The request, to which the federal agency had already responded and set a target date of July 30, 2022 (subject to the fulfillment of certain conditions), formally initiated communication with the FDA concerning the development of DehydraTECH-CBD as a treatment for hypertension (https://ibn.fm/PoR5K).
“We are excited to take this important first regulatory step with the FDA for the development of our DehydraTECH-CBD for the treatment of hypertension,” commented Lexaria President John Docherty. “Submission of this request letter initiates formal communication with the FDA regarding our IND clinical trial plans in order to help define the critical path for clinical development and marketing approval of our potentially very significant new hypertension therapeutic.”
The pre-IND meeting is intended to confirm the details and acceptability of Lexaria’s IND-enabling work, which is set to be completed after the meeting has been held. This work has been made possible by the company’s growing body of evidence showing DehydraTECH-CBD’s capacity to potentially treat hypertension.
Through its successfully completed studies – HYPER-H21-1, HYPER-H21-2, and HYPER-H21-3 – Lexaria has not only demonstrated that DehydraTECH-CBD lowers the human blood pressure relative to placebo and reduces arterial stiffness but also that it does not cause any adverse effects. According to the company’s recent statement, efficacy and the lack of negative side effects are the two main goals of FDA-registered clinical studies.
Following the pre-IND meeting and the completion of the IND-enabling development program, Lexaria expects to then proceed with its full IND application filing expected in late 2022 or early 2023.
Meanwhile, the company also celebrated another milestone that saw it expand the list of licensees. In a recent announcement, Lexaria reported that its wholly owned subsidiary, Lexaria Pharmaceutical Corp., had awarded a five-year, non-exclusive DehydraTECH license to AnodGen Bioceuticals of Ireland (https://ibn.fm/RxIVe).
The license allows AnodGen, a newly established contract manufacturing organization business, to manufacture and distribute DehydraTECH-processed cannabinoid active pharmaceutical ingredient (“API”) powders within Europe (including the UK), Australia, and New Zealand. The license also covers pharmaceutical and medical product applications for psychoactive cannabinoids and medical product applications for non-psychoactive cannabinoids. AnodGen can also manufacture and sell the API powders to third-party companies for their own products, subject to the fulfillment of specific conditions. On its part, Lexaria will receive royalty fees for all API powders sold that utilize the DehydraTECH drug delivery technology.
This licensing agreement comes on the heels of two similar agreements that saw Lexaria Pharmaceutical Corp. grant a European and UK license to medical cannabis manufacturer Valcon Medical A/S (https://ibn.fm/atOS7) and a license to Premier Wellness Science Co. Ltd to deploy DehydraTECH within the Japanese non-pharmaceutical market (https://ibn.fm/ALjfa).
“We are focused on larger national and international applications for DehydraTECH, primarily but not entirely in the pharmaceutical sector. These are our areas of interest that we expect will provide significant revenue streams over time…,” commented Lexaria CEO Chris Bunka in a January letter to shareholders (https://ibn.fm/cZwn3). With the series of out-licenses announced recently, Lexaria appears to be inching closer to realizing this goal.
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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