FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE) has begun a Phase 1 human study of its anti-inflammatory ultra-micronized-palmitoylethanolamide (PEA) after winning approval from the Ethics Committee of the Alfred Hospital in Victoria, Australia.
The drug works by targeting receptors in patients’ endocannabinoid system and is designed to treat the symptoms associated with conditions such as fibromyalgia. The new Phase 1 study is meant to evaluate the safety, tolerability and pharmacokinetics of the drug in healthy volunteers.
"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," CEO Raza Bokhari said in a statement.
Bokhari gave credit to the head of the company’s BioSciences division.
"I must congratulate Dr. Edward Brennan, President of FSD Pharma’s BioSciences Division, and his very qualified team on delivering this milestone on schedule,” Bokhari said. “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 US 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 Pharma is focused on the research and development of cannabinoid-based treatments for several central nervous system disorders, including fibromyalgia, and irritable bowel syndrome.
Headquartered at the former Kraft plant in Cobourg, Ontario, with large expansion potential, FSD also grows medical-grade cannabis at its 25,000 square foot facility in Ontario.
Through its wholly-owned subsidiary FV Pharma Inc, the group is a licensed producer under Canada's Cannabis Act, having received its cultivation license in October 2017 and its sale for medical purposes license in April 2019.
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