FSD Pharma Inc. (HUGE) Receives Regulatory Clearance for Its Proposed Phase-1 Clinical Trial of Lucid-21-302 (Lucid-MS), First-in-Class Multiple Sclerosis Drug Candidate

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.

“There is an acute need today for effective, non-immunomodulatory, neuroprotective therapeutics, especially for the treatment of progressive stages of MS,” said Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals, 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 steppingstone 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.”

“Our drug development team worked hard to advance this pipeline into clinical stages,” added Dr. Andrzej Chruscinski, Vice-President, Clinical and Scientific Affairs at Lucid Psycheceuticals. “We continue to evaluate our clinical development strategy to advance Lucid-MS into next phases of development efficiently in collaboration with our expert advisors.”

According to MS International Foundation (Atlas of MS 2020 – Epidemiology report found at www.msif.org/resource/atlas-of-ms-2020/), the number of people diagnosed worldwide with Multiple Sclerosis in 2020 is estimated at 2.8 million, up significantly from 2.3 million in 2013. The U.S. and Canada rank amongst the highest in the world in prevalence per capita, with 288 cases per 100,000 people and 250 cases per 100,000 people, respectively. MS can occur at any age, but the average age for diagnosis globally is 32 years. MS is also diagnosed in youths, with at least 30,000 children under the age of 18 (or ~1.5% of the total number of cases) living with the disease. MS is far more frequent in females (69% of cases) than in males (31% of cases). There currently is no cure for MS. According to Allied Market Research, the global MS therapies market was valued at $22.99 billion in 2018 and will grow at a 2.5% compound annual growth rate to reach $28.0 billion by 2026 (https://www.alliedmarketresearch.com/multiple-sclerosis-market).

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