FDA Approves FSD Pharma to Submit I.N.D. for Compound to Treat Covid-19 Patients
Positive results in Phase 1 human safety study
FSD Pharma is a specialty biotech pharmaceutical R&D company. Further, FSD Pharma BioSciences, a wholly-owned subsidiary, is focused on developing over time multiple applications of the company’s lead compound FSD201, ultra-micronized palmitoylethanolamide (PEA), by down-regulating the cytokines to effectuate an anti-inflammatory response.
Moreover, they have successfully completed a Phase 1 first-in-human safety and tolerability study for FSD201. The study found the compound to be safe with no serious adverse side effects. This study also validated considerable scientific literature published in Europe that claims safety and tolerability of micro-PEA. Further, ultra-micronized PEA has been dispensed in Italy and Spain as a prescription anti-inflammatory medical food supplement since 2004, with no serious adverse side effects reported.
Additionally, on June 1, 2020, the Company received permission from the U.S. Food and Drug Administration (FDA) to submit an Investigational New Drug (“IND”) application 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. This is to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
FV Pharma, a wholly-owned subsidiary, is a licensed producer under Canada’s Cannabis Act and Regulations, having received its cultivation license on October 13, 2017 and its full Sale for Medical Purposes license on June 21, 2019. The Company is also licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.
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