FSD Pharma Begins Phase 1 In-human Safety and Tolerability Study of Ultra Micro-Palmitolylethanolamide (PEA)

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[{"type":"text","content":"\n\n\n\nFSD Pharma Begins Phase 1 In-human Safety and Tolerability Study of Ultra Micro-Palmitolylethanolamide (PEA)\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\n\nCanada NewsWire\nTORONTO, March 9, 2020\n\n\n\nTORONTO, March 9, 2020 /CNW/ - FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) (FRA: 0K9A) (\"FSD Pharma\" or the \"Company\") today announced receipt of approval from the Ethics Committee of the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia, to initiate a Phase 1, 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.  \n\n \n \n \n \n \n \n\n \nThe study is now underway at 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. \n\"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,\" said Raza Bokhari, MD, Executive Co-Chairman & CEO. \"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 prescr...

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