Quantum Biopharma Ltd. ( 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 ( QNTM ).
"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 ( QNTM ) 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 ( PSIL ) .
Price Action: At last check Tuesday, QNTM shares were trading lower by 8.63% to $25.40.
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