Quantum BioPharma Gets FDA Clearance to Start Phase 2 Trial of Lucid-MS for Multiple Sclerosis

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 way for the company to initiate Phase 2 clinical development of its patented, first-in-class multiple sclerosis (MS) candidate. The upcoming trial will be a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of Lucid-MS in people with MS, using both clinical and radiological measures. Trial start-up activities, including site selection, are already underway, with patient enrollment and drug administration expected to begin as soon as possible.

The significance of this FDA clearance lies in Lucid-MS's unique mechanism of action. Unlike existing MS therapies that primarily modulate the immune system, Lucid-MS is designed to provide neuroprotection by inhibiting demyelination—the process by which the protective myelin sheath around nerve fibers is damaged. The candidate targets protein arginine deiminase 2 (PAD2), an enzyme implicated in myelin degradation. In preclinical models, Lucid-MS has demonstrated the ability to prevent and reverse myelin breakdown, a distinguishing feature that could potentially alter the course of MS rather than just manage symptoms.

Quantum BioPharma reported that Lucid-MS exhibited a favorable safety profile and was well tolerated in prior Phase 1 trials involving healthy participants. The company also noted it had more than $10 million in cash, digital assets, and liquid investments as of March 31, 2026, which may support the advancement of the program. The company's pipeline includes drug candidates for neurodegenerative, metabolic, and alcohol misuse disorders, with Lucid-MS as the lead compound under its wholly owned subsidiary, Lucid Psycheceuticals Inc.

The approval of the IND application is a critical milestone for Quantum BioPharma, as it transitions Lucid-MS from earlier-stage testing to a pivotal Phase 2 study that will provide key data on its potential efficacy. This development also highlights the growing interest in neuroprotective approaches for MS, which could complement or improve upon current treatments that focus on reducing immune-mediated attacks. If successful, Lucid-MS could offer a new therapeutic option for the millions of people worldwide living with MS.

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