Lexaria Bioscience Corp. (NASDAQ:LEXX) saw its shares move up slowly Monday on word it has successfully filed a pre-Investigational New Drug (“IND”) meeting request letter with the U.S. Food and Drug Administration (“FDA”).
The FDA has already responded to and confirmed Lexaria’s filing. A target date of July 30, has been provided to Lexaria, subject to certain conditions being met.
The request for a pre-IND meeting formally initiates communications with the FDA regarding development of Lexaria's DehydraTECH-CBD for the treatment of hypertension. The purpose of the pre-IND meeting will be to confirm the details and acceptability of Lexaria's ongoing IND-enabling development program to be completed thereafter prior to proceeding with its full IND application filing expected in late 2022 / early 2023.
“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,” said 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.”
In pre-clinical and exploratory clinical studies conducted to-date, Lexaria has repeatedly evidenced efficacy in utilizing DehydraTECH-CBD to reduce blood pressure while avoiding negative serious adverse effects. Efficacy and lack of negative side effects are two major objectives of FDA-registered clinical studies.
LEXX shares began the week up one cent to $2.20.
