Quantum BioPharma (NASDAQ: QNTM), a biopharmaceutical company developing therapies for neurodegenerative and metabolic disorders, has taken a significant step toward advancing its lead multiple sclerosis (MS) drug candidate, Lucid-MS, by signing a Study Start-Up Agreement with the clinical research business of Thermo Fisher Scientific. The agreement, announced via Quantum BioPharma (NASDAQ: QNTM), moves the program from planning into execution and sets the stage for a Phase 2 trial in progressive MS, a form of the disease with limited treatment options.
The partnership matters because it pairs Quantum's innovative approach with a global contract research organization (CRO) renowned for its expertise in central nervous system (CNS) and MS studies. Thermo Fisher's clinical research business, acquired in 2021 for $17.4 billion, will support study start-up activities and related clinical research services. "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. "We look forward to working with Thermo Fisher, our investigators and clinical research partners as we initiate the Lucid-MS Phase 2 study."
Lucid-MS is an investigational, first-in-class new chemical entity that targets peptidyl arginine deiminase 2 (PAD2), an enzyme implicated in the hypercitrullination of myelin proteins. By inhibiting PAD2, Lucid-MS aims to protect the integrity of the myelin sheath, a novel neuroprotective approach that differs from most MS drugs, which primarily modulate the immune system. Andrzej Chruscinski, Quantum's President of Scientific and Clinical Affairs, noted that the Phase 2 study will evaluate this innovative approach using clinical and radiological measures. "Entering into the Study Start-Up Agreement allows us to begin the operational work required," he said.
The timing is critical. In August, the U.S. Food and Drug Administration cleared Quantum's Investigational New Drug application for Lucid-MS. Now, with a CRO in place, the company can operationalize the trial. MS affects an estimated 3 million people worldwide, including nearly 1 million in the United States. The disease damages myelin, leading to often disabling symptoms. Progressive forms of MS, the focus of the Lucid-MS trial, have the greatest unmet need. 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 released this year identified urgent needs, including effective treatment of disease progression and therapies that repair myelin damage.
The commercial stakes are also notable. Quantum cites Grand View Research in projecting that the MS therapeutics market will exceed $38 billion by 2030. Lucid-MS has shown a favorable safety profile in Phase 1 trials and demonstrated the ability to prevent and reverse measures of myelin degradation in preclinical models. The randomized, double-blind, placebo-controlled Phase 2 trial will assess efficacy, safety, and tolerability in people with progressive MS, using clinical and radiological endpoints tied to disease progression.
For more information, visit www.QuantumBioPharma.com. The latest news and updates relating to QNTM are available in the company's newsroom at https://ibn.fm/QNTM.
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