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 and metabolic disorders, today announced that an interim report has been received for the first-in-human (“FIH“) single ascending dose Phase I clinical trial evaluating the Company’s novel drug candidate Lucid-21-302 (“Lucid-MS“), an orally-administered treatment for Multiple Sclerosis (“MS“). This interim blinded report was issued on August 17, 2023 for the first 4 cohorts, with an addendum report describing the results of the fifth cohort due by the end of the month.

The report, issued by Biopharma Services Inc. as the clinical research organization under contract to FSD, states that “Lucid-21-302 was demonstrated to be safe and well-tolerated in single oral doses in healthy volunteers. Individual concentrations and PK parameters of Cohorts 1 to 4 are very encouraging for further development activity.”

“We are thrilled with the results described in this report, and consider this to be a major milestone for our team. We are looking forward to continuing the development of Lucid-MS for potential treatment of progressive MS, an indication where there is an unmet need for novel, non-immunomodulatory treatments.”

-Dr. Andrzej Chruscinski, Vice President Clinical and Scientific Affairs at Lucid Psycheceuticals, a wholly owned subsidiary of FSD Pharma

In Multiple Sclerosis, the brain, spinal cord, and optic nerves that make up the central nervous system (CNS) are attacked by immune system, and damage to CNS leads to the symptoms of MS. Secondary progressive multiple sclerosis is a course of the disease in which neurologic function worsens and disability increases, and typically follows the initial course of relapsing-remitting MS. According to estimates from the National Multiple Sclerosis Society, 27-45 for every 100,000 people in the United States have SPMS. According to the National Multiple Sclerosis Society, 10 to 15 percent of people with MS have primary progressive MS, an advanced disease course characterized by gradual worsening neurologic symptoms and an accumulation of disability. Clinically isolated syndrome, one of the 4 multiple sclerosis disease courses, is also due to demyelination, in addition to inflammation, and patients experience neurological symptoms due to damage to CNS. The current disease-modifying therapies work primarily by reducing inflammation in the CNS but are not very effective for the treatment of nerve degeneration.

Dr. Lakshmi P. Kotra, CEO of Lucid Psycheceuticals said, “Our objective in this FIH study was to determine the safety, tolerability, and pharmacokinetic profile of Lucid-MS in humans and we seem to have been successful in meeting those goals. Development of novel, non-immunomodulatory therapies with new mechanisms of action is a very high priority for all stages of MS. We are inspired to expeditiously pursue the next stages of clinical development to bring such novel therapies for patients.”

About FSD Pharma

FSD Pharma Inc. is a biotechnology company with two candidates in different stages of development. Lucid Psychss Inc., a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-MS and UNBUZZD™. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders. UNBUZZD™ is a proprietary formulation of natural ingredients, vitamins, and minerals to help with liver and brain function for the purposes of potentially quickly relieving from the effects of alcohol consumption, such as inebriation, and restoring normal lifestyle.