Quantum Biopharma Ltd (QNTM)

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https://www.businesswire.com/news/home/20200830005006/en/FSD-Pharma-Announces-Phase-2-Clinical-Trial


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TORONTO--(BUSINESS WIRE)--FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (“FSD Pharma” or the “Company”) today announced that it has submitted to the U.S. Food and Drug Administration (“FDA”) an Investigational New Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus (the “FSD201 COVID-19 Trial”). Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. As previously announced, FSD Pharma 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.

COVID-19 Trial Design

The FSD201 COVID-19 Trial will be a randomized, controlled, double-blind, multicenter study, conducted at 25-30 sites in North America to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care ("SOC") compared to SOC alone in hospitalized patients with documented COVID-19 disease.