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Tuesday, February 7, 2023

FSD OKd for Phase-1 Trial of Lucid-21-302 (Lucid-MS), First-in-Class Multiple Sclerosis Drug

 FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, today announces the receipt of a No Objection Letter (“NOL”) from Health Canada regarding the Company’s proposed Phase 1 clinical trial of LUCID-21-302 (“Lucid-MS”), a novel drug candidate for the treatment of Multiple Sclerosis (“MS”). The NOL provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada.

The first-in-human clinical trial will 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”) that has been the subject of more than 11 years of research and development. In preclinical models, Lucid-MS has been shown 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. Preclinical evidence has demonstrated Lucid-MS to promote functional recovery in experimental animal models of MS (https://fsdpharma.com/our-science/). Based upon current evidence, Lucid-MS is non-immunomodulatory, an important distinction in the potential for developing new, safe options for treating MS.

https://www.biospace.com/article/releases/fsd-pharma-receives-regulatory-clearance-for-its-proposed-phase-1-clinical-trial-of-lucid-21-302-lucid-ms-first-in-class-multiple-sclerosis-drug-candidate/

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