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June 4, 2020updated 12 Jul 2022 11:48am

FSD Pharma gets FDA approval for Phase II Covid-19 trial

FSD Pharma has received approval from the US Food and Drug Administration (FDA) to design a Phase IIa clinical trial of FSD-201 for the treatment of Covid-19.

FSD Pharma has received approval from the US Food and Drug Administration (FDA) to design a Phase IIa clinical trial of FSD-201 for the treatment of Covid-19.

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The company intends to develop FSD-201 for its anti-inflammatory properties, which are expected to avoid the cytokine storm related to acute lung injury in hospitalised Covid-19 patients.

FSD-201 is a formulation of ultramicronised palmitoylethanolamide (PEA). FSD Pharma acquired the global rights to the drug from Italian pharmaceutical firm Epitech Group.

Epitech markets ultramicronized PEA to treat chronic pain and inflammatory conditions in Italy.

FSD Pharma executive co-chairman and CEO Raza Bokhari said: “We contacted the FDA in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronised PEA for patients suffering from symptoms of Covid-19, based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines.

“Numerous studies over the past 40 years also validate the efficacy and safety of ultramicronised PEA in the treatment and prophylactic effects in respiratory infections.”

The company intends to design the Phase IIa trial as a randomised, controlled, double-blind, multi-centre study to assess the safety and efficacy of FSD-201 in the US.

Participants will receive FSD-201 600mg or 1,200mg twice-daily plus standard of care (SOC) or SOC alone. The treatment period is estimated to be 14 days.

The primary endpoint of the study is the ability of FSD-201 plus SOC to offer a significant improvement in clinical status.

Key secondary objectives include safety, objective assessments, length of time to clinical progression, and length of hospital stay. The exploratory endpoint is cytokine clearance determine using Enzyme Linked Immunosorbent Assay (ELISA).

Patients who experience clinical benefit may continue on their assigned treatment until study completion.

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