Quantum BioPharma Taps Thermo Fisher to Launch Phase 2 Lucid-MS Trial, Advancing Novel Neuroprotective Approach for Multiple Sclerosis

Quantum BioPharma Ltd. (NASDAQ: QNTM) has taken a decisive step toward advancing a novel treatment for multiple sclerosis (MS) by signing a Study Start-Up Agreement with the clinical research business of Thermo Fisher Scientific. The agreement, announced this week, covers implementation of the Phase 2 trial for Lucid-MS, Quantum's lead drug candidate for MS, moving the program from planning into execution. The partnership pairs Quantum's innovative neuroprotective approach with Thermo Fisher's extensive expertise in central nervous system (CNS) and MS studies, positioning the trial for rigorous clinical evaluation.

The significance of this announcement lies in its potential to address a major unmet need in MS treatment. Most existing MS drugs work by modulating or suppressing the immune system, but Lucid-MS is designed around a different strategy: protecting the nerve's myelin sheath, the damage of which leads to disease progression and disability. "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."

The timing is critical. In August, the U.S. Food and Drug Administration cleared Quantum's Investigational New Drug application for Lucid-MS. Now, just two months later, the company has secured a global contract research organization to carry out the trial. 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. Treatment options for progressive forms of MS, which are the focus of the Lucid-MS trial, are particularly limited. A 2023 study in Neurology and Therapy described these options 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.

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. The Phase 2 trial will be a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of Lucid-MS in people with progressive MS, with clinical and radiological endpoints tied to disease progression.

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 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 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.

This agreement provides Quantum with a clear operational path and an experienced partner as Lucid-MS enters its next stage of clinical development. If successful, the trial could validate a new treatment paradigm for MS, one that focuses on protecting and repairing myelin rather than solely suppressing the immune system. For the millions affected by progressive MS, such an approach could offer hope where current therapies fall short.