Quantum Biopharma Ltd. (NASDAQ:QNTM) announced on Tuesday that its subsidiary Huge Biopharma Australia has received the clinical study report for a Phase 1, randomized, double-blind, placebo-controlled multiple ascending dose trial evaluating the safety and pharmacokinetics of Lucid-MS in healthy adults.
The report confirms that daily dosing of Lucid-MS posed no safety or tolerability concerns, clearing a critical regulatory milestone and supporting the compound's advancement.
Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis (MS).
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It is a patented New Chemical Entity (NCE) that has been shown in preclinical models to prevent demyelination, which is a hallmark of MS and other neurogenerative diseases and is characterized by damage to the myelin sheath surrounding nerve fibers.
"The CSR allows us to advance the clinical development of Lucid-MS as it is a critical component of the investigational new drug (IND) application with the FDA," said Dr. Andrzej Chruscinski, Vice-President of Clinical and Scientific Affairs at Quantum BioPharma.
"Results and observations from the first-in-human studies including this MAD investigation give us the confidence that Lucid-MS is safe and tolerable in healthy volunteers," noted Dr. Lakshmi P. Kotra, Director at Quantum BioPharma and Professor at the University of Toronto, who led the discovery of the compound.
According to Benzinga Pro, QNTM stock has gained over 388% in the past year. Investors can gain exposure to the stock via AdvisorShares Psychedelics ETF (NYSE:PSIL).
Price Action: At last check Tuesday, QNTM shares were trading lower by 8.63% to $25.40.
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