HUGE - Dosing underway in FSD Pharma's mid-stage FSD201 study in COVID-19

FSD Pharma (HUGE) has dosed the the first patient in its Phase 2a clinical trial of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) for the treatment of hospitalized patients with COVID-19. The primary objective of trial is to determine whether FSD201 plus standard of care ((SOC)) provides a significant improvement in the clinical status of patients (e.g., shorter time to symptom relief).Secondary objectives include determining whether FSD201 plus SOC demonstrates additional benefit in terms of safety; objective assessments such as length of time to normalization of fever, oxygen saturation and clinical progression, including time to mechanical ventilation or hospitalization, and length of hospital stay.The exploratory endpoint is cytokine clearance as measured by Enzyme Linked Immunosorbent Assay ((ELISA)). The treatment period for patients in the FSD201 COVID-19 Trial is 14 days and the primary end point is determined at 28 days.Shares up 8% premarket.

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Dosing underway in FSD Pharma's mid-stage FSD201 study in COVID-19