FSD Pharma Submits a Phase-1 Multiple Ascending Doses Clinical Trial Application for Lucid-21-302 (Lucid-MS) for Ethics Committee Review in Australia

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[{"type":"text","content":"FSD Pharma Submits a Phase-1 Multiple Ascending Doses Clinical Trial Application for Lucid-21-302 (Lucid-MS) for Ethics Committee Review in AustraliaTORONTO, ON / ACCESSWIRE / May 7, 2024 / 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 to address ailments affecting millions worldwide, today announces the submission to ethics of a trial entitled \"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants.\" This clinical trial application is submitted for review by a human ethics review committee (HREC) in Australia, a step that is necessary to obtain permission to initiate the multiple ascending dose (MAD) trial. The MAD trial follows the Phase-1 single ascending dose (SAD) trial that was recently completed.Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis (MS). It is a patented New Chemical Entity that has been shown in preclinical models to prevent 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. In the prior Phase-1 single ascending dose (SAD) study, Lucid-21-302 was shown to be safe and well-tolerated in the dose range of 50-300 mg administered once orally to healthy adults, with no difference in pharmacokinetics between the fed and fasted states.\"We are eager to study multiple doses of Lucid-21-302 in healthy volunteers as this marks an important next step in advancing Lucid-21-302 into an optimally designed phase-2 clinical trial. We are very optimistic about the potential of Lucid-21-302 as a first-in-class, non-immunomodulatory treatment for MS as it progresses to the next phase of clinical development,\" said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at FSD Pharma.About FSD PharmaFSD Pharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with dr...

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