Quantum BioPharma Ltd. has completed oral dosing in both 180-day chronic toxicity and toxicokinetic studies for its therapeutic candidate Lucid-MS, representing a significant milestone for the company's multiple sclerosis program. The studies are designed to support the company's planned Investigational New Drug application with the U.S. Food and Drug Administration and advance the design of a Phase 2 clinical trial in people with multiple sclerosis.
Lucid-MS is a patented new chemical entity that has demonstrated the ability to prevent and reverse myelin degradation in preclinical models. Myelin degradation represents the underlying mechanism of multiple sclerosis, a chronic autoimmune disease affecting the central nervous system. The completion of these extended toxicity studies moves this first-in-class therapeutic candidate closer to clinical-stage development, potentially addressing a significant unmet medical need for the approximately 2.8 million people worldwide living with multiple sclerosis.
Quantum BioPharma, which trades on NASDAQ under the symbol QNTM and on the Canadian Securities Exchange under the same symbol, is a biopharmaceutical company focused on developing innovative treatments for challenging neurodegenerative and metabolic disorders as well as alcohol misuse disorders. Through its wholly owned subsidiary Lucid Psycheceuticals Inc., the company is advancing its lead compound Lucid-MS through the research and development pipeline.
The company maintains additional business interests through strategic investments and product development. Quantum BioPharma invented unbuzzd™ and spun out its over-the-counter version to Unbuzzd Wellness Inc., retaining 20.11% ownership as of March 31, 2025, along with royalty payments of 7% of sales until payments total $250 million, after which the royalty drops to 3% in perpetuity. The company retains full rights to develop similar products for pharmaceutical and medical applications. Additional information about the company is available through its newsroom at https://ibn.fm/QNTM.
This development represents progress in the neurodegenerative disease treatment landscape, where effective therapies that address the underlying mechanisms of conditions like multiple sclerosis remain limited. The successful completion of extended toxicity studies typically represents a critical step before human clinical trials can commence, as regulatory agencies require comprehensive safety data before approving investigational new drug applications. For patients with multiple sclerosis, who often experience progressive disability despite current treatments, new therapeutic approaches that target myelin preservation and repair could potentially offer improved outcomes and quality of life.
The biopharmaceutical industry closely monitors such milestones as they indicate progression through the challenging drug development pipeline, where many candidates fail to advance beyond preclinical stages. Quantum BioPharma's progress with Lucid-MS demonstrates the company's commitment to advancing novel treatments for complex neurological conditions, potentially positioning it as a contributor to the next generation of multiple sclerosis therapies. The planned Phase 2 clinical trial, supported by these toxicity studies, will provide crucial data on the compound's safety and efficacy in human subjects, moving the therapeutic candidate closer to potential regulatory approval and patient access.
