FSD Pharma Inc. announced favorable topline results from its Phase 1 randomized, double-blind, placebo-controlled study of ultramicronized palmitoylethanolamide (PEA), or FSD201. This single-site study was conducted at the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia and enrolled 48 healthy adult men and women.
The trial sequentially tested single ascending doses ranging from 600 mg to 2400 mg tablets and multiple ascending doses ranging from 600 mg to 1200 mg tablets administered twice daily for 7 consecutive days. The single ascending dose subjects also were tested for food effect.
The study found ultramicronized PEA to be safe and well tolerated. Mild and self-limiting side effects were reported and were deemed unlikely to be related to study drug. There were no abnormal laboratory findings or ECGs observed during the study and no serious adverse events were reported. No subjects withdrew due to an adverse event and all eligible subjects completed all doses. The pharmacokinetic profile of FSD201 in this study is still being analyzed.
The study was led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network, Australia.
“We are delighted to be reporting favorable topline findings from our Phase 1 first-in-human safety and tolerability study with FSD201. I congratulate our pharmaceutical team, led by Dr. Edward Brennan. This study has also successfully validated the considerable scientific literature published over the years in Europe that claims safety and tolerability of micro-PEA,” said Raza Bokhari, MD, Executive Co-Chairman & CEO.
“Our immediate plans for FSD201 include submitting these Phase 1 trial results for publication in a peer-reviewed journal and advancing this compound into a Phase 2a proof-of-concept trial for the treatment of COVID-19,” continued Dr. Bokhari. “The U.S. Food and Drug Administration recently gave the Company permission to submit an Investigational New Drug application for the use of FSD201 to treat COVID-19. We contacted the FDA after becoming aware that Italian physicians and scientists were advocating for use of ultramicronized 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 and may help mitigate a cytokine storm.”
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.