FSD Pharma has filed an application with the US Food and Drug Administration (FDA) seeking its approval to launch a phase 2 trial for FSD201 (ultramicronised palmitoylethanolamide, or ultramicronised PEA) in Covid-19 patients.

In this connection, the Canadian pharma company has submitted an investigational new drug (IND) application for FSD201 with the US regulator.

The phase 2 trial will be a randomised, controlled, double-blind, multicentre study that will be held at 25-30 sites across North America. It will evaluate FSD201’s efficacy and safety in two dosings of 600mg and 1200mg given daily twice along with standard of care (SOC) compared to SOC alone in hospitalised patients with documented COVID-19 disease.

FSD Pharma is developing the drug candidate for its anti-inflammatory properties to prevent the cytokine storm resulting from the acute lung injury in hospitalised Covid-19 patients.

The company was given approval by the FDA in early June 2020 to design a phase 2a clinical trial to assess the drug candidate in the treatment of patients with suspected or confirmed Covid-19 diagnosis.

At that time, the company said that the primary endpoint of the mid-stage trial is to determine if FSD-201 plus SOC delivers a considerable improvement in clinical status during the 14-day treatment period.

Key secondary objectives of the trial are expected to be the evaluation of the investigational treatment in delivering additional benefit in terms of safety, objective assessments. These include the length of time to normalisation of fever, length of time to improving oxygen saturation levels, and length of time to clinical progression including the time to mechanical ventilation or hospitalisation, and length of stay in the hospital.

In late June, FSD Pharma said that its ultramicronised PEA was found to be safe and well tolerated in a phase 1 first-in-human safety and tolerability study at the Alfred Hospital in Mebourne, Australia in 48 healthy adult men and women.

The company said that its phase 2 clinical trial programme is subject to a toxicology study being favourable and on ongoing laboratory studies to be successfully completed besides access to additional financing and review by the FDA of the IND application.

FSD Pharma stated: “The duration and cost of clinical trials can vary significantly depending on multiple factors, including the enrollment rate of patients, country in which trials are conducted, and specific trial protocols required.

“The process of developing pharmaceutical products and receiving the necessary regulatory approvals for commercialization typically takes several years.”