FSD Pharma Completes Dosing of First Cohort in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee Recommends Commencing Dosing of Second Cohort

FSD Pharma Inc. (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, today announced the completion of dosing the first cohort of patients in the Company’s Phase I clinical trial of Lucid-21-302 (“Lucid-MS”). The clinical trial (ClinicalTrials.gov Identifier: NCT05821387 ), being conducted by FSD Pharma through the Company’s wholly owned subsidiary Lucid Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a small molecule inhibitor of hypercitrullination, as a novel drug candidate for the treatment of Multiple Sclerosis (“MS”).

The clinical trial is a randomized, double-blind, placebo controlled, single ascending dose (“SAD”) and multiple ascending dose (“MAD”) study with the primary outcomes evaluating the safety, tolerability, and pharmacokinetics of Lucid-MS in healthy volunteers under fed and fasted conditions. Enrollment will be comprised of five SAD cohorts and two MAD cohorts. Each SAD and MAD cohort will enroll eight participants (for a total of 56 participants) randomized to six active and two placebo groups. Participants in the active group will receive single or multiple doses of Lucid-MS. For the SAD cohort with food effect, all eight participants will receive Lucid-MS.

Lucid-MS is a patented first-in-class, New Chemical Entity (“NCE”) and a neuroprotective compound with a novel mechanism of action for the treatment of MS. In preclinical models, Lucid-MS has been shown to prevent myelin degradation (demyelination), a hallmark pathology feature 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 on current evidence, Lucid-MS is non-immunomodulatory agent, an important distinction in the potential for developing new, safe options for treating MS.

FSD Pharma Inc. 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 ultra-micronized PEA formulation, for the treatment of inflammatory diseases. Lucid Psychss Inc., a wholly owned subsidiary, is 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, and expanding this category, the Company is investigating other products addressing acute medical needs due to the abuse of drugs such as alcohol. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.