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 being dispensed in Italy and Spain as a prescription based medical food supplement since 2004.
The Company received approval for an Investigational New Drug Application (IND) from the Food and Drug Administration (FDA) for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus. A randomized, controlled, double-blind, multicenter Phase 2 clinical study is currently underway and is expected to cover 352 hospitalized COVID 19 patients.
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.