Quantum BioPharma Signs Contract with Thermo Fisher Scientific's Clinical Research Business to Implement Phase 2 Lucid-MS Trial in Multiple Sclerosis
NASDAQ: QNTM | FRA: 0K91
Overview
Quantum BioPharma Ltd. announced that it has entered into a Study Start-Up Agreement ("SUA") with the clinical research business of Thermo Fisher Scientific to implement the company's Phase 2 clinical trial of Lucid-21-302 ("Lucid-MS") for multiple sclerosis ("MS"), according to the company.
According to the company, the execution of the contract represents an important milestone in the clinical development of Lucid-MS and marks the initiation of formal study start-up activities. Following the company's receipt of FDA clearance to proceed with the planned Phase 2 clinical trial, Quantum BioPharma is advancing into implementation, the company stated.
Key Highlights
- Quantum BioPharma has entered into a Study Start-Up Agreement with the PPD™ Clinical Research Business within Thermo Fisher Scientific, described by the company as a leading global contract research organization with extensive experience supporting global clinical development programs across therapeutic areas, including central nervous system ("CNS") and multiple sclerosis studies.
- Under the terms of the contract, Thermo Fisher will support Quantum BioPharma in implementing the Phase 2 clinical trial, including study start-up activities and related clinical research services, according to the company.
- The Phase 2 trial will evaluate the efficacy, safety, and tolerability of Lucid-MS in people with progressive forms of MS, according to the company.
- The randomized, double-blind, placebo-controlled study is designed to evaluate clinical and radiological endpoints relevant to disease progression and disease biology, the company stated.
- The agreement follows the company's receipt of FDA clearance to proceed with the planned Phase 2 trial.
Strategic/Operational Context
"We are pleased to enter into a contract with the clinical research business of Thermo Fisher as we advance the Lucid-MS program toward Phase 2," said Zeeshan Saeed, Chief Executive Officer of Quantum BioPharma. "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. We look forward to working with Thermo Fisher, our investigators and clinical research partners as we initiate the Lucid-MS Phase 2 study."
Andrzej Chruscinski, President, Scientific and Clinical Affairs at Quantum BioPharma, said, "Lucid-MS is designed around a novel neuroprotective approach that targets demyelination rather than solely modulating the immune system. The Phase 2 study will provide an important opportunity to evaluate this approach using clinical and radiological measures. Entering into the Study Start-Up Agreement allows us to begin the operational work required, and we look forward to working closely with Thermo Fisher and our clinical investigators as the program advances."
Michael Cioffi, Vice President and General Manager, Neuroscience, Clinical Research, Thermo Fisher, said, "We're proud to partner with Quantum BioPharma in advancing their neuro-degenerative clinical program in multiple sclerosis. 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. By combining scientific expertise with operational excellence, we can help bring promising new therapies closer to the patients who need them."
According to the company, Lucid-MS is an investigational, first-in-class New Chemical Entity designed to provide neuroprotection through inhibition of demyelination. Quantum BioPharma is developing Lucid-MS as a potential treatment for multiple sclerosis, with a focus on progressive forms of the disease. By targeting protein arginine deiminase 2 (PAD2), an enzyme implicated in myelin degradation, Lucid-MS is being developed as a potential therapeutic approach to address demyelination and neurodegenerative processes associated with MS. In preclinical models, Lucid-MS has demonstrated the ability to prevent and reverse measures of myelin degradation, according to the company.
According to the company, multiple sclerosis affects approximately 2.8 million people worldwide (source: Atlas of MS, Third Edition, PMC/NCBI), and the MS therapeutic market is projected to exceed $38 billion by 2030 according to Grand View Research. The company states that its approach of targeting demyelination directly positions Lucid-MS to address current unmet patient needs and potentially capture meaningful market share in the emerging neuroprotective segment.
What to Watch Next
- Implementation of study start-up activities for the Phase 2 Lucid-MS trial with Thermo Fisher's PPD Clinical Research Business.
- Progress of the randomized, double-blind, placebo-controlled Phase 2 study evaluating efficacy, safety, and tolerability of Lucid-MS in people with progressive forms of MS.
About Quantum BioPharma Ltd.
Quantum is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), Quantum is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum invented UNBUZZD™ and spun out its OTC version to Unbuzzd Wellness Inc. ("Unbuzzd") (formerly, Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.48% (as of June 30, 2026) of Unbuzzd. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses.
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