Quantum BioPharma (NASDAQ: QNTM), a biopharmaceutical company developing therapies for neurodegenerative and metabolic disorders, has taken a major step toward advancing its lead multiple sclerosis (MS) drug candidate. The company 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, moving the program from planning into execution. The agreement follows the U.S. Food and Drug Administration's clearance of Quantum's Investigational New Drug application for Lucid-MS in August.
Lucid-MS is designed around a novel neuroprotective approach that targets demyelination rather than solely modulating the immune system. MS affects an estimated 3 million people worldwide, including nearly 1 million in the United States. The disease damages myelin, the protective coating around nerve fibers, and is often disabling. The gap is widest in progressive forms of the disease, 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 drew on survey responses from more than 2,800 people living with MS and identified urgent unmet needs, including effective treatment of disease progression and therapies that repair myelin damage.
"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," stated 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 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," said Chruscinski.
Thermo Fisher's clinical research business, which the company acquired in 2021 for $17.4 billion, is a leading global contract research organization with deep experience 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. "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 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 (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. The candidate has also been tested in people. Quantum has said Lucid-MS showed a favorable safety profile and was well tolerated 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. It is designed to assess clinical and radiological endpoints tied to disease progression. Lucid-MS remains investigational, and the company has not announced enrollment dates or trial sites. Even so, the agreement gives the program a clear operational path and an experienced partner as it enters its next stage.
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