FSD Pharma, Inc., is a publicly traded holding company since May 2018.
FSD BioSciences, Inc., a wholly-owned subsidiary, is a specialty biotech pharmaceutical R&D company focused on developing over time multiple applications of its lead compound, FSD201, ultra-micronized palmitoylethanolamide (PEA). Ultra-micro PEA is known to target the CB2 receptors of the endocannabinoid system of the human body and acts by down-regulating the pro-inflammatory cytokines to effectuate an anti-inflammatory response.
The company has successfully completed Phase 1 first-in-human safety and tolerability study for FSD201 and has found the compound to be safe with no serious adverse side effects. This study also validated considerable scientific literature already published in the European Union that claims safety and tolerability of micro-PEA. Ultra-micro PEA is currently beings dispensed in Italy and Spain as a prescription based medical food supplement since 2004.
The company received permission from the Food and Drug Administration (FDA) on June 1, 2020 to submit an Investigational New Drug Application (IND) for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. The Company is focused on developing FSD201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.