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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 announced that through its subsidiary, HUGE Biopharma Australia Pty Ltd., it entered into agreement with iNGENu CRO Pty Ltd on March 26, 2024 to conduct "A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants".
"We are very pleased to formalize this agreement and to collaborate with iNGENu to conduct this clinical study," said Zeeshan Saeed, Co-Chairman and CEO of FSD Pharma. "This clinical study builds on our prior Phase 1 study of Lucid-21-302 and represents an important next step in our mission to develop novel therapeutics for the treatment of MS."
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 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 a prior Phase 1 single ascending dose study, Lucid-21-302 was shown to be safe and well-tolerated in the dose range of 50-300 mg p.o. administered once to healthy adults, with no difference in pharmacokinetics between the fed and fasted states.
"Over the next several days and weeks, our R&D team will closely work with iNGENu to start this clinical study swiftly." added Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at FSD Pharma. "We are very eager to complete this clinical trial as efficiently as possible, and are encouraged by the strong data from the prior Phase 1 single ascending dose study supporting the safety and tolerability of Lucid-21-302."
