FSD Pharma Phase II COVID-19 trial gets go-ahead

By Jenni Spinner contact

- Last updated on GMT

(chayakorn lotongkum/iStock via Getty Images Plus)
(chayakorn lotongkum/iStock via Getty Images Plus)

Related tags: COVID-19, Coronavirus, Clinical trials, Phase II, FDA approval

The company’s Phase II trial of ultramicronized PEA has received FDA approval and expects to begin dosing patientparticipants as early as next month.

FSD Pharma has landed US Food and Drug Administration (FSD) authorization for initiation of a Phase II study for a potential COVID-19 treatment. The company believes FSD201, or ultramicronized palmitoylethanolamide (PEA) , or ultramicronized PEA) could be useful in addressing the inflammatory response in severe COVID-19 patients that could lead to potentially deadly cytokine storm.

Raza Bokhari, executive co-chairman and CEO of FSD Pharma, told FSD Pharma researchers believe the drug has potential to prove effective in relieving the severe inflammation associated with severe cases of the virus.

FSD201 is made up of synthetic molecules that mimic cannabinoids. Micro PEA is a unique drug and it is believed to act as an anti-inflammatory​,” he explained.

According to Bokhari, the drug was promoted between 1969 and 1979 as a treatment for influenza and the common cold; at the time, trials indicated PEA was an effective prophylactic in respiratory infection, with no registered side effects. Scientists behind this research felt the treatment could serve as a quick therapeutic answer for flu epidemics.

FSD Pharma anticipates it will start dosing patient participants in October. Bokhari said the commencement of the Phase II trial constitutes a “major milestone​” for the company’s pharmaceutical team, led by Dr. Edward Brennan.

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​,” Bohkari explained. “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​.”

The FSD201 COVID-19 Trial is a randomized, controlled, double-blind, multicenter study, conducted on 352 patients to assess the efficacy and safety of FSD201 orally 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, fatigue, difficulty breathing) and newly documented positive COVID-19 disease.

According to FSD Pharma, the trial’s primary objective is to determine whether FSD201 plus SOC provides a significant improvement in the clinical status of patients (e.g., shorter time to symptom relief). 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 of oxygen saturation and length of time to clinical progression, including time to mechanical ventilation or hospitalization, and length of hospital stay.

The exploratory endpoint reportedly involves cytokine clearance as measured by enzyme linked immunosorbent assay (ELISA). The treatment period for patients in the FSD201 COVID-19 trial is 14 days, and the primary endpoint determined at 28 days.

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