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 completion of the first-in-human (“FIH”) sentinel dosing of Lucid-21-302 (“Lucid-MS”) in the Company’s Phase I clinical trial evaluating its novel drug candidate as an orally-administered treatment for Multiple Sclerosis (“MS”). The sentinel dose was completed on Sunday, April 16, 2023.
“Dosing the sentinel subject is a major achievement for our team and culmination of more than a decade of very promising research by a seasoned development team passionate about changing the future treatment paradigm for patients dealing with the debilitating effects of MS. Current MS treatments are immunomodulatory and include repeated subcutaneous or intramuscular injections for treating the symptoms of MS. We envision a day where an oral medication will protect or even help repair myelin in the central nervous system, a hallmark feature of the disease. We are optimistic Lucid-MS has this type of paradigm-shifting potential and the sentinel dosing is a critical step in advancing this pipeline forward.”
Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals, a wholly owned subsidiary of FSD Pharma
The FIH clinical trial is evaluating the safety and tolerability of Lucid-MS, a patented first-in-class New Chemical Entity (“NCE”) and neuroprotective compound with a novel mechanism of action for the treatment of MS. Lucid-MS. In preclinical models, Lucid-MS has been shown to prevent myelin degradation (demyelination), a hall mark 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 upon current evidence, Lucid-MS is non-immunomodulatory, an important distinction in the potential for developing new, safe options for treating MS.
MS is a chronic inflammatory and degenerative disorder of the central nervous system (brain and spinal cord). Presentation of symptoms can be diverse, including fatigue, numbness and tingling, muscle spasms, blurred vision, dizziness, pain, mobility problems, cognitive impairment and decline, depression, anxiety, and more. Although current treatments reduce the relapse rate, there remains a significant unmet need to slow disease progression and address the progressive stages of MS, which LUCID-MS may address.
The MS Society ( https://mssociety.ca/resources/news/article/atlas-of-ms-report-shows-28-million-people-worldwide-live-with-multiple-sclerosis ) shows that someone in the world is diagnosed with MS every five minutes. 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. Deaths attributed to MS are commonly caused by infection (e.g., respiratory, urinary tract-related); conditions associated with advanced disability and immobility (e.g., aspiration pneumonia, chronic respiratory disease). 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 ( www.alliedmarketresearch.com/multiple-sclerosis-market ).
About FSD Pharma
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.