FSD Pharma Inc (CSE:HUGE, NASDAQ:HUGE) told investors it has received a No Objection Letter (NOL) from Health Canada for its proposed Phase 1 clinical trial of LUCID-21-302 (Lucid-MS), a novel drug candidate for the treatment of multiple sclerosis (MS), providing it with regulatory approval to move forward with the trial in Canada.
The Toronto-based biopharmaceutical company said 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.
“There is an acute need today for effective, non-immunomodulatory, neuroprotective therapeutics, especially for the treatment of progressive stages of MS,” Dr Lakshmi Kotra, CEO of FSD subsidiary Lucid Psycheceuticals, said in a statement. “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 stepping stone in our mission to develop novel therapeutics for the treatment of MS.”
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The company explained that Lucid-MS is a patented New Chemical Entity 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.
It also noted that Preclinical evidence has demonstrated Lucid-MS to promote functional recovery in experimental animal models of MS. Based upon current evidence, it said Lucid-MS is non-immunomodulatory, an important distinction in the potential for developing new, safe options for treating MS.
“Our drug development team worked hard to advance this pipeline into clinical stages,” Dr Andrzej Chruscinski, vice president of clinical and scientific affairs at Lucid Psycheceuticals added. “We continue to evaluate our clinical development strategy to advance Lucid-MS into next phases of development efficiently in collaboration with our expert advisors.”
FSD Pharma is building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide. The company has three drug candidates in different stages of development.
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