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Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) announced that the U.S. Food and Drug Administration has approved its Investigational New Drug (“IND”) application for Lucid-MS (Lucid-21-302), clearing the company to advance the patented, first-in-class multiple sclerosis candidate into Phase 2 clinical development. The planned randomized, double-blind, placebo-controlled study will evaluate efficacy, safety and tolerability in people with MS using clinical and radiological measures. Trial start-up activities, including site selection, are underway, with patient enrollment and drug administration expected to begin as quickly as possible.
Lucid-MS is designed to provide neuroprotection by inhibiting demyelination, differentiating it from existing MS therapies that primarily focus on modulating the immune system. The candidate targets protein arginine deiminase 2 (“PAD2”), an enzyme implicated in myelin degradation, and has demonstrated the ability to prevent and reverse myelin breakdown in preclinical models. Quantum BioPharma said Lucid-MS demonstrated a favorable safety profile and was well tolerated in prior Phase 1 trials in healthy participants. The company reported more than $10 million in cash, digital assets and liquid investments as of March 31, 2026.
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