FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, has received notification that it can move forward with its proposed phase 1 clinical trial in Canada. The notification came in the form of a No Objection Letter (“NOL”) from Health Canada. The letter gives FSD Pharma regulatory approval to proceed with its clinical trial of LUCID-21-302 (“Lucid-MS”), a novel drug candidate for the treatment of multiple sclerosis. The first-in-human clinical trial is designed to evaluate the safety and tolerability of Lucid-MS. A neuroprotective compound with a unique mechanism of action for the treatment of MS, Lucid-MS is a patented new chemical entity (“NCE”). In previous studies and development, Lucid-MS exhibited potential to prevent myelin degradation (demyelination), a known cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers in the central nervous system. “There is an acute need today for effective, nonimmunomodulatory, neuroprotective therapeutics, especially for the treatment of progressive stages of MS,” said Lucid Psycheceuticals CEO Dr. Lakshmi Kotra in the press release (Lucid Psycheceuticals is a wholly owned subsidiary of FSD Pharma). “We are excited to receive the NOL regulatory clearance, and look forward to initiating the first clinical trial of this promising candidate as a critical stepping stone in our mission to develop novel therapeutics for the treatment of MS. We will continue to work with Health Canada and other regulators worldwide to complete clinical investigations as soon as we can.”
To view the full press release, visit https://ibn.fm/oBld1
About FSD Pharma Inc.
FSD Pharma is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences Inc., a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound FSD201, a proprietary ultramicronized palmitoyl ethylamine (“PEA”) for the treatment of inflammatory diseases. Lucid Psycheceuticals Inc. is a wholly owned subsidiary focused on the research and development of its lead compounds: Lucid-PSYCH and Lucid-MS. Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders. For more information about the company, please visit www.FSDPharma.com.
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