The trial is a randomized, controlled, double-blind, multicenter study, conducted on 352 patients to assess the efficacy and safety of FSD201 dosed at 600 milligrams (mg) 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).
In a statement, the company said the primary objective of the trial is to determine whether FSD201 plus SOC provides a significant improvement in the clinical status of patients (shorter time to symptom relief).
READ: FSD Pharma wins FDA nod to begin Phase 2 clinical trial for its lead drug micro-PEA to treat coronavirus patients
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, length of time to improvement in oxygen saturation, and length of time to clinical progression, including the time to mechanical ventilation or hospitalization, and length of hospital stay.
Known as ultra-micronized PEA, the drug is a naturally occurring fatty acid similar to an endocannabinoid, one of a suite of molecules found in cannabis that targets endocannabinoid receptors in the human body.
FSD-201 works by reducing lung inflammation caused by small proteins called cytokines that are central to the “cytokine storm” phenomenon, where the body attacks its own cells rather than just fighting off the COVID-19 disease caused by the SARS-CoV-2 virus.
This so-called storm of an "over-exuberant" inflammatory response causes acute lung injury in hospitalized patients and is a leading cause of death for those infected.
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