FSD Pharma Inc. Announces Termination of FSD-201 Phase 2 Clinical Trial


However, will continue to evaluate other potential commercial opportunities with FSD-201 TORONTO–(BUSINESS WIRE)–FSD Pharma Inc. (Nasdaq:HUGE) (CSE:HUGE) (FRA:0K9) (the “Company” or “FSD”) announced today that it intends to terminate the Phase 2 clinical trial of ultra-micronized palmitoylethanolamide (“PEA”), or FSD-201, for use in treating COVID-19. FSD-201 stabilizes mast cells and down-regulates the pro-inflammatory cytokines to effectuate an anti-inflammatory response; it is also known to target the CB2 receptors of the endocannabinoid system of the human body. The Company has previously successfully completed a Phase 1 first-in-human safety and tolerability study for FSD-201 and the compound to be safe with no serious adverse side effects. In June 2020, the United States Food and Drug Administration (the “FDA”) approved the submission of an Investigational New Drug Application (“IND”) for the use of FSD-201 to treat COVID-19 and in September 2020, a randomized, controlled, double-blind, multicenter Phase 2 clinical study was approved by the FDA. The Company is working to complete and publish these findings in the near future. As previously disclosed, following the May 14, 2021 annual general and special meeting of shareholders, the Company retained Bloom Burton Securities Inc. (“Bloom Burton”) to undertake a review of its Phase 2 clinical program to assist the Company in determining its viability and, more broadly, evaluating the general current commercial viability of FSD-201. In particular, the Company was concerned with the pace of progress in advancing the Phase 2 clinical study during a period in which COVID-19 treatments evolved significantly and competitive products were being successfully advanced. Bloom Burton recently reported its findings and the Company concluded that, while there are potential commercial opportunities for FSD-201, specifically the treatment of COVID-19 by FSD-201 is unlikely to be commercially viable. Based on this information, the Company has elected to terminate the current Phase 2 clinical…

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Source : FSD Pharma Inc. Announces Termination of FSD-201 Phase 2 Clinical Trial

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