Vancouver, British Columbia--(Newsfile Corp. - June 23, 2020) - FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FSE: 0K9), a specialty, biotech pharmaceutical R&D company, focused on developing, over time, multiple applications of its lead compound FSD201, has announced favorable topline results from its Phase I first-in-human safety and tolerability study of ultra-micronized palmitolylethanolamide or PEA.
This randomized, double-blind, placebo-controlled study of PEA, or FSD201, was conducted at the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia.
The trial sequentially tested 48 healthy adult men and women with 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 was led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network, Australia's largest and most experienced Phase 1 clinical research organization. The study found ultra-micronized PEA to be safe and well tolerated. There were no abnormal laboratory findings or ECGs observed during the study and no serious adverse events were reported, although mild and self-limiting side effects were reported and were deemed unlikely to be related to study drug. 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.
Dr. Raza Bokhari, Executive Co-Chairman and CEO, stated: "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."
FSD Pharma acquired worldwide rights, excluding Italy and Spain, to ultra-micronized PEA from Epitech Group, an Italian pharmaceutical company that invented and holds the patents until 2034. Ultra-micronized PEA has been dispensed in Italy and Spain as a prescription anti-inflammatory medical food supplement since 2004, with no serious adverse side effects reported.
On June 1, 2020, the company received permission from the U.S. Food and Drug Administration to submit an Investigational New Drug application for the use of FSD201 to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
Dr. Raza Bokhari, added: "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. 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 ultra-micronized 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."
FSD's wholly-owned subsidiary, FV Pharma, is a licensed producer under Canada's Cannabis Act and Regulations, having received its cultivation license in October 2017 and its full Sale for Medical Purposes license in June 2019. The company is licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.
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.
For more information, please visit the company's website, www.FSDpharma.com, or contact Sandy Huard, Head of Communications, at 647-864-7969 or by email at sandy@FSDpharma.com. For investor relations in Canada email IR@FSDpharma.com. In the United States, contact Sanjay M. Hurry of LHA Investor Relations, who can be reached at 212-838-3777 or by email at SHurry@lhai.com.
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