Vancouver, British Columbia--(Newsfile Corp. - March 10, 2020) - FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FSE: 0K9), a specialty, biotech pharmaceutical R&D company focused on developing, over time, a robust pipeline of FDA approved synthetic compounds targeting the endocannabinoid system of the human body to treat certain diseases of the central nervous system and autoimmune disorders of the skin, GI tract and the musculoskeletal system, is initiating a new study at the Alfred Hospital in Australia.
This new Phase 1 study at the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria, is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ultra-micronized-PEA in normal healthy volunteers.
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In July 2019, the company acquired Arizona-based Prismic Pharmaceuticals for $17.5 million as a platform company and installed a world class expert in the field, Dr. Ed Brennan, as the President of the Division. It is through this acquisition that FSD Pharma is developing opioid-sparing prescription drugs utilizing the micronized formulations of palmitolylethanolamide (PEA), which are being used in this new study.
The study, the first-in-human safety and tolerability trials for its lead candidate, PP 101 micro-PEA, is now underway at the Alfred Hospital in Melbourne and is being led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network, Australia's largest and most experienced Phase 1 clinical research organization.
Dr. Raza Bokhari, Executive Co-Chairman and CEO, stated: "The initiation of this Phase 1 in-human safety and tolerability clinical study of ultra-micronized formulation of PEA is a ground-breaking milestone for our company as we stride forward to find novel anti-inflammatory treatment outcomes for patients by targeting the CB2 receptors of the endocannabinoid system. I must congratulate Dr. Edward Brennan, President of FSD Pharma's BioSciences Division, and his very qualified team on delivering this milestone on schedule. Dr. Brennan's decades of experience in drug development is very noteworthy, and I share his confidence that this Phase 1 in-human study based on U.S. FDA-approved guidelines will produce favorable data. The study would validate considerable scientific literature already published, over the years, in the European Union, that claims safety and tolerability of micro-PEA, which is being dispensed in Italy and Spain as a prescription-based medical food supplement since 2004."
FSD's wholly-owned subsidiary, FV Pharma, is a licensed producer under Canada's Cannabis Act and Regulations, having received its cultivation license on October 13, 2017 and its full Sale for Medical Purposes license on June 21, 2019. The company is licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.
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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