BetterLife Pharma Inc (CSE:BETR, OTCQB:BETRF) said it has received a positive written response from the US Food and Drug Administration (FDA) to its pre-investigational new drug (pre-IND) application for the treatment of major depressive disorder (MDD) with BETR-001.
The company said BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD) and is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials.
It said the FDA response is in general agreement with the company’s planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling nonclinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.
READ: BetterLife Pharma reports positive pre-clinical data on TD-0148A to treat depression
“We are very pleased with the outcome of the BETR-001 pre-IND meeting with the FDA,” CEO Dr Ahmad Doroudian said in a statement.
“The response from the FDA confirms that our current program will support the filing of BETR-001’s IND application and initiation of human clinical trials by the third quarter of this year.”
BetterLife noted that being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches.
“Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year,” Doroudian added.
BetterLife Pharma is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuropsychiatric and neurological disorders.
Contact the author at stephen.gunnion@proactiveinvestors.com