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 after the U.S. Food and Drug Administration cleared its Investigational New Drug application in August. According to the announcement, 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.
The partnership matters because it pairs a novel treatment approach with an experienced global contract research organization. Most MS drugs work by quieting the immune system, but Lucid-MS is designed around a neuroprotective approach that targets demyelination—the damage to myelin, the protective coating around nerve fibers—rather than solely modulating the immune system. "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. Thermo Fisher's clinical research business, which the company acquired in 2021 for $17.4 billion, brings deep expertise in central nervous system and MS studies. "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.
The need for new MS therapies is significant. MS affects an estimated 3 million people worldwide, including nearly 1 million in the United States. The disease is often disabling, and the gap is widest in progressive forms, which are the focus of the Lucid-MS trial. A 2023 study in Neurology and Therapy described treatment options for progressive MS as limited, finding that many patients remain untreated or continue to decline despite available therapies. 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. 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.
The commercial stakes are also notable. Quantum's announcement cites Grand View Research in projecting that the MS therapeutics market will exceed $38 billion by 2030. While Lucid-MS remains investigational and enrollment dates and trial sites have not been announced, the agreement gives the program a clear operational path and an experienced partner as it 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. This news was originally distributed by BioMedWire, one of the brands within the Dynamic Brand Portfolio at IBN, which provides InvestorWire for wire solutions, editorial syndication to 5,000+ outlets, press release enhancement, social media distribution, and corporate communications solutions. Please see full terms of use and disclaimers at https://www.BioMedWire.com/Disclaimer.
