Quantum BioPharma Taps Thermo Fisher for Phase 2 MS Trial

Quantum BioPharma (NASDAQ: QNTM) has signed a Study Start-Up Agreement with Thermo Fisher Scientific's clinical research business to implement a phase 2 trial of Lucid-MS, its lead drug candidate for multiple sclerosis. The agreement moves the innovative treatment from planning into execution, following FDA clearance of its Investigational New Drug application in August. Lucid-MS is a first-in-class new chemical entity that targets peptidyl arginine deiminase 2 (PAD2), an enzyme implicated in the hypercitrullination of myelin proteins. Unlike most MS drugs that modulate the immune system, Lucid-MS aims to protect and repair myelin, the protective coating around nerve fibers. Preclinical models have shown the compound can prevent and reverse measures of myelin degradation, and phase 1 trials demonstrated a favorable safety profile.

The randomized, double-blind, placebo-controlled phase 2 trial will evaluate the efficacy, safety, and tolerability of Lucid-MS in people with progressive MS, assessing clinical and radiological endpoints tied to disease progression. Thermo Fisher's clinical research business, acquired in 2021 for $17.4 billion, is a leading global contract research organization with deep expertise in central nervous system and MS studies. "Following FDA clearance to proceed with the phase 2 study, initiating study start-up activities with a leading global CRO with extensive CNS and MS experience represents an important next step," said Quantum BioPharma CEO Zeeshan Saeed. Quantum's President of Scientific and Clinical Affairs, Andrzej Chruscinski, noted that the study will provide an important opportunity to evaluate the neuroprotective approach using clinical and radiological measures.

The partnership addresses a critical unmet need. MS affects an estimated 3 million people worldwide, including nearly 1 million in the United States. Progressive forms of the disease, the focus of the Lucid-MS trial, have limited treatment options. A 2023 study in Neurology and Therapy described treatment options for progressive MS as limited, with many patients remaining untreated or continuing to decline. A National MS Society report identified urgent unmet needs, including effective treatment of disease progression and therapies that repair myelin damage. With the MS therapeutics market projected to exceed $38 billion by 2030, according to Grand View Research, this agreement positions Quantum BioPharma to advance a potentially transformative therapy. For more information, visit www.QuantumBioPharma.com.