Quantum BioPharma (NASDAQ: QNTM) has signed a Study Start-Up Agreement with the clinical research business of Thermo Fisher Scientific to initiate the Phase 2 trial of Lucid-MS, its lead drug candidate for multiple sclerosis. The agreement, announced by Quantum BioPharma (NASDAQ: QNTM), moves the program from planning into execution and sets the stage for a rigorous clinical test of a novel approach to treating MS.
Most existing MS drugs work by quieting the immune system. Lucid-MS is designed around a neuroprotective strategy that targets demyelination—the damage to the protective myelin sheath around nerve fibers—rather than solely modulating immune activity. This differentiated mechanism could address a significant gap in treatment, particularly for progressive forms of MS, where options are limited.
The partnership with Thermo Fisher’s clinical research business, a leading global contract research organization with deep expertise in central nervous system and MS studies, provides Quantum with an experienced partner to manage the complexities of a Phase 2 trial. “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.”
Quantum’s President of Scientific and Clinical Affairs, Andrzej Chruscinski, noted that the Phase 2 study will 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 notable: in August, the FDA cleared the Investigational New Drug application for Lucid-MS, and roughly two months later, Quantum has secured a global CRO to carry out the work.
The need for new therapies is significant. 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 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 substantial experience to the collaboration. “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 high. Quantum’s announcement cites Grand View Research in 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, an enzyme implicated in the hypercitrullination of myelin proteins. By inhibiting PAD2, Lucid-MS is being investigated for its potential to protect myelin integrity. In preclinical models, the compound has demonstrated the ability to prevent and reverse measures of myelin degradation, and it has shown a favorable safety profile in Phase 1 trials.
Under the contract, Thermo Fisher will support study start-up activities and related clinical research services for the randomized, double-blind, placebo-controlled trial, which will evaluate the efficacy, safety, and tolerability of Lucid-MS in people with progressive MS. While enrollment dates and trial sites have not been announced, the agreement provides a clear operational path forward. For more information, visit www.QuantumBioPharma.com.
