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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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About Quantum BioPharma Ltd.
Quantum 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 drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum invented UNBUZZD(TM) and spun out its OTC version to a company, Unbuzzd Wellness Inc. (“Unbuzzd”) (formerly, Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.84% (as of March 31, 2026) of Unbuzzd at www.unbuzzd.com. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd(TM) until payments to Quantum total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses.
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