FSD Pharma has secured approval from the US Food and Drug Administration (FDA) to design a phase 2a clinical trial to evaluate the efficacy of FSD-201 (ultramicronised palmitoylethanolamide or ultramicronised PEA) to treat patients with suspected or confirmed Covid-19 diagnosis.
The regulator has provided the company with the permission to submit an investigational new drug application (IND) to use FSD-201 for the treatment of Covid-19, the disease resulted due to the SARS-CoV-2 virus.
FSD Pharma purchased worldwide rights, excluding Italy and Spain, to ultramicronised PEA from Epitech Group.
Epitech is an Italian pharmaceutical firm that invented and holds the patents for ultramicronised PEA until 2034. PEA is a naturally occurring fatty acid amide, which was first identified in the yolks of chicken eggs.
FSD Pharma is involved in the development of FSD-201 with anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalised Covid-19 patients.
The randomised, controlled, double-blind, and the US multicentre study will be designed to evaluate the efficacy and safety of FSD-201 dosed 600mg or 1200mg twice-daily plus standard of care (SOC) against SOC alone in symptomatic patients with clinical presentation compatible with Covid-19.
The primary endpoint of the trial is to determine whether the FSD-201 plus SOC offers a significant improvement in clinical status.
The crucial secondary objectives comprise of determining if FSD-201 plus SOC shows additional benefit in terms of safety, objective evaluations such as length of time to normalisation of fever, length of time to improvement of oxygen saturation and length of time to clinical progression including time to mechanical ventilation or hospitalisation, and length of hospital stay.
In addition, the study’s exploratory endpoint is cytokine clearance as measured by enzyme-linked immunosorbent assay (ELISA).
FSD Pharma executive co-chairman and CEO Dr Raza Bokhari said: “FDA’s permission to design a proof-of-concept study in Covid-19 patients evaluating clinical doses of FSD-201 is a paradigm shift for FSD Pharma and is the result of outstanding work conducted by Dr. Edward Brennan, President FSD BioSciences, and his team.”
Recently, Roche has announced the commencement of phase III clinical study of Actemra/RoActemra plus remdesivir in hospitalised patients with severe Covid-19 pneumonia.