Quantum BioPharma (NASDAQ: QNTM), a biopharmaceutical company developing therapies for neurodegenerative and metabolic disorders, has signed a Study Start-Up Agreement with the clinical research business of Thermo Fisher Scientific to implement the Phase 2 trial of Lucid-MS, its lead drug candidate for multiple sclerosis (MS). The agreement moves Lucid-MS from planning into execution, following the U.S. Food and Drug Administration's clearance of its Investigational New Drug application in August.
The partnership matters because it pairs Quantum's novel neuroprotective approach with a leading global contract research organization (CRO) that has deep expertise in central nervous system and MS studies. Unlike most MS drugs that work by quieting the immune system, Lucid-MS targets demyelination—the damage to myelin, the protective coating around nerve fibers—rather than solely modulating the immune system. This distinct mechanism could address the urgent unmet needs of progressive MS patients, who often face limited treatment options and continue to decline despite available therapies.
"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."
Andrzej Chruscinski, Quantum's President of Scientific and Clinical Affairs, noted that the Phase 2 study will provide an important opportunity to evaluate the 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. MS affects an estimated 3 million people worldwide, including nearly 1 million in the United States. 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, drawing on survey responses from more than 2,800 people living with MS, identified urgent unmet needs, including effective treatment of disease progression and therapies that repair myelin damage.
Thermo Fisher's clinical research business, which the company acquired in 2021 for $17.4 billion, brings extensive experience in CNS and MS trials. "We're proud to partner with Quantum BioPharma in advancing their neuro-degenerative clinical program in multiple sclerosis," said Michael Cioffi, vice president and general manager, neuroscience, clinical research, at Thermo Fisher. "Our team brings deep experience in CNS and MS trials, along with an integrated approach that connects strategy and execution to help deliver these complex studies."
The commercial stakes are also notable. Quantum's announcement cites Grand View Research projecting that the MS therapeutics market will exceed $38 billion by 2030. 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 is being investigated for its potential to protect the integrity of the myelin sheath. In preclinical models, the compound has demonstrated the ability to prevent and reverse measures of myelin degradation, and it showed a favorable safety profile in Phase 1 trials in healthy participants.
Under the contract, Thermo Fisher will support study start-up activities and related clinical research services. The randomized, double-blind, placebo-controlled 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. While enrollment dates and trial sites have not been announced, the agreement provides a clear operational path and an experienced partner as the program enters its next stage.
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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