FSD Pharma has dosed the first patients in its phase 2a clinical trial designed to assess FSD201 (ultramicronised palmitoylethanolamide or ultramicronised PEA) for the treatment of hospitalised patients with Covid-19.
The randomised, controlled and double-blind study will recruit 352 patients in between 25 and 30 medical centres and hospitals in North America.
The multicentre study will evaluate the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily along with standard of care (SOC) compared to SOC alone in hospitalised patients with documented Covid-19 disease.
FSD trial’s primary objective is to determine whether FSD201 in combination with SOC significantly improves clinical status of patients.
The trial’s secondary objectives consists of determining whether FSD201 plus SOC shows additional benefit in terms of safety, objective assessments such as length of time to normalization of fever, length of time to improvement of oxygen saturation and length of time to clinical progression and length of hospital stay.
Cytokine clearance as measured by enzyme linked immunosorbent assay (ELISA) is the exploratory endpoint of the trial.
FSD Pharma stated that 14 days is the treatment period for patients in the trial and the primary end point will be determined at 28 days.
In August, FSD Pharma submitted an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for FSD201. In September, the regulator approved the IND to begin a phase 2 clinical trial of FSD201 to treat Covid-19.
In June this year, FSD Pharma first secured FDA approval to design a phase 2a clinical trial to evaluate the efficacy of FSD-201 o treat patients with suspected or confirmed Covid-19 diagnosis.