FSD Pharma (CSE:HUGE, NASDAQ:HUGE) Inc said it has entered into an agreement with Covar Pharmaceuticals Inc, a contract development and manufacturing services organization, to start work on providing research quantities of its drug candidate, Lucid-PSYCH, on an exclusive basis for further clinical evaluation.
FSD has selected Lucid-PSYCH (formerly Lucid-201), a psychoactive compound, 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.
READ: FSD Pharma closes its all-stock acquisition of Canada’s Lucid Psycheceuticals
“This agreement with Covar continues our momentum in completing advanced preclinical studies and scale-up activities,” FSD interim CEO Anthony Durkacz said in a statement.
“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.”
FSD said clinical development of Lucid-PSYCH is continuing under Dr Lakshmi Kotra, CEO of wholly-owned subsidiary Lucid Psycheceuticals, with Investigational New Drug (IND)-enabling studies currently underway. Preclinical efficacy studies are being conducted in collaboration with the University Health Network, the largest health research organization in Canada.
The company noted that Covar’s research and development (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.
Under the agreement, Covar will produce non-GMP (good manufacturing practice) and GMP Lucid-PSYCH for use in FSD’s planned pre-clinical and Phase 1 clinical trials, respectively.
FSD Pharma (CSE:HUGE, NASDAQ:HUGE) is a publicly-traded holding company that owns subsidiary FSD Pharma BioSciences Inc, a specialty biotech pharmaceutical R&D firm focused on developing multiple applications of its lead anti-inflammatory drug FSD-201.
Lucid Psycheceuticals has exclusive worldwide rights to novel compounds shown to prevent and potentially reverse the biochemical mechanisms of progressive multiple sclerosis in multiple preclinical animal models.
Additionally, FSD is seeking to develop a unique psychoactive (psychedelic-based) therapeutic aimed at addressing neurodegenerative disorders, a multibillion-dollar mental health market.
Contact the author at stephen.gunnion@proactiveinvestors.com