Quantum BioPharma Receives United States FDA Clearance To Proceed with Lucid-MS Phase 2 Trial in Progressive Multiple Sclerosis:

August 10, 2026 07:00 ET  | Source: Quantum BioPharma

Major Regulatory Milestone Positions Company to Initiate Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Patented First-in-Class Neuroprotective Therapy Targeting Demyelination 

Lucid-MS Advances Novel Disease-Modifying Approach Targeting Multi-Billion Dollar Progressive MS Market with Significant Unmet Medical Need Worldwide

TORONTO, Aug. 10, 2026 (GLOBE NEWSWIRE) — Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma”), a transformative biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for challenging neurological, metabolic, and alcohol misuse disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for Lucid-MS (Lucid-21-302), enabling Quantum BioPharma to immediately advance its patented, first-in-class multiple sclerosis program into Phase 2 clinical development. This will be the first time in history patients with MS consume the unique Lucid-MS new chemical entity molecule with a goal of reversing some or all of their loss of bodily control or mobility.

This strategic milestone clears a pivotal regulatory pathway, enabling Quantum BioPharma to begin its planned Phase 2 clinical trial of Lucid-MS in individuals with progressive multiple sclerosis (MS). The Company is working with a leading global clinical research organization with significant experience in neurodegenerative studies, to support implementation of the planned disease-modifying Phase 2 study. Trial start-up activities, including site selection, are already underway, and the Company expects to initiate patient enrollment and drug administration as quickly as possible.

Addressing a Substantial Unmet Medical Need

Progressive forms of MS—including primary progressive MS (PPMS) and secondary progressive MS (SPMS)—represent an area of substantial unmet medical need worldwide, with limited therapeutic options currently available. According to market research, the Primary Progressive Multiple Sclerosis (PPMS) Treatment Market is projected to expand from USD $1.16 billion in 2025 to USD $1.31 billion by 2026, reflecting a CAGR of 13.7% (The Business Research Company, 2026). The overall global MS therapeutics market is anticipated to reach approximately USD $38.62 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.93% (Grand View Research, 2026). Despite the availability of disease-modifying therapies (DMTs), a substantial proportion of patients with progressive MS remain untreated or continue to experience disability progression, highlighting the critical need for innovative treatments that not only modulate the immune response but also promote remyelination and neuroprotection.

Lucid-MS is a patented, new chemical entity investigational drug candidate designed to provide neuroprotection through the inhibition of demyelination, a key contributor to disability progression in multiple sclerosis. Unlike most existing therapies that focus primarily on modulating the immune system, Lucid-MS represents a differentiated approach targeting the underlying neurodegeneration—a novel mechanism with the potential to address the root cause of disease advancement in progressive MS.

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