FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients

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[{"type":"text","content":"FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients- FDA has authorized randomized, controlled, double-blind, multicenter study on 352 patients TORONTO, ON / ACCESSWIRE / September 28, 2020 / FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE.CN) (\"FSD Pharma\" or the \"Company\") today announced that the U.S. Food and Drug Administration (\"FDA\") has authorized the initiation of a Phase 2 study 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\"). The company is expected to start dosing patients in October 2020. We believe FSD201 may have the potential to address the over-exuberant inflammatory response characterized by COVID-19 infection that may lead to a cytokine storm and ultimately death.\"Commencing a phase 2 clinical trial to treat hospitalized COVID-19 patients is a major milestone achieved by our pharmaceutical team led by Dr. Edward Brennan and a huge step forward for FSD Pharma,\" said Dr. Raza Bokhari, Executive Co-Chairman & CEO. We are joining the global fight against the deadly SARS-CoV-2 virus with a hope to demonstrate down-regulation of the over-expressed immune response in COVID-19 patients leading to better treatment outcome. FSD201 is formulated as a tablet for oral dosing and is a safe compound with no known serious adverse side effects. Numerous studies over the past 40 years have validated micronized PEA for its efficacy and safety in the treatment of, and prophylactic effects with respect to, other respiratory infections.\"COVID-19 Trial DesignThe FSD201 COVID-19 Trial is a randomized, controlled, double-blind, multicenter study, conducted on 352 patients 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. Eligible patients will present symptoms consistent with influenza/coronavirus signs (fever, dry cough, malaise, difficulty breathing) and newly documented positive COVID-19 disease.The primary objective of the FSD201 COVID-19 Trial is to determine whether FSD201 plus SOC provides a significant improvement in the clinical status of patients (e.g., shorter time to symptom reli...

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