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 trial will evaluate a novel neuroprotective approach that targets demyelination 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," 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."
The need for new MS treatments is significant. 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. 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.
Most MS drugs work by quieting the immune system. 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. It has also shown a favorable safety profile and was well tolerated in Phase 1 trials in healthy participants.
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 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. 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.
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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