TORONTO– FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9) (“FSD Pharma” or the “Company”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today it has entered into an agreement with Covar Pharmaceuticals Inc. (“Covar”), a contract development and manufacturing services organization (“CDMO”), to commence work on providing research quantities of FSD’s drug candidate, Lucid-PSYCH, on an exclusive basis for further clinical evaluation.
A psychoactive compound, Lucid-PSYCH (formerly Lucid-201) has been selected by FSD to advance its research into the treatment of major depressive disorders based on analysis of the drug candidate’s pharmaceutical and metabolic properties processed via machine learning algorithms, as well as for its potential proprietary position.
Clinical development of Lucid-PSYCH is continuing under the leadership of Dr. Lakshmi P. Kotra, B.Pharm.(Hons), Ph.D., the Chief Executive Officer of Lucid Psycheceuticals Inc., of FSD’s wholly-owned subsidiary, with Investigational New Drug (“IND”)- enabling studies currently underway, and preclinical efficacy studies being conducted in collaboration with the University Health Network, the largest health research organization in Canada. Covar’s R&D facility is licensed to handle psychoactive compounds such as Lucid-PSYCH, which are Controlled Substances listed under the Controlled Drugs and Substances Act, Canada. Pursuant to the agreement, Covar will produce Non-GMP and GMP Lucid-PSYCH for use in FSD’s planned pre-clinical and Phase 1 clinical trials, respectively.
“This agreement with Covar continues our momentum in completing advanced preclinical studies and scale-up activities,” commented Anthony Durkacz, Interim CEO of FSD Pharma. “This potentially sets the stage for us to achieve our goal of moving Lucid-PSYCH from bench to clinic by obtaining IND approval and initiating a Phase 1 clinical study.”