Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) has announced the completion of oral dosing in both 180-day chronic toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS). This milestone supports the company’s planned Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), moving the program closer to clinical-stage development for this first-in-class therapeutic candidate aimed at treating multiple sclerosis.
The studies are intended to support the design and advancement of a Phase 2 clinical trial of Lucid-MS in people with multiple sclerosis. Lucid-MS is a patented new chemical entity shown in preclinical models to prevent and reverse myelin degradation, which is the underlying mechanism of multiple sclerosis. The completion of these long-term toxicity studies is a critical regulatory requirement for advancing to human trials.
Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for challenging neurodegenerative and metabolic disorders, as well as alcohol misuse disorders. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc., the company is focused on the research and development of Lucid-MS. The company also invented unbuzzd(TM) and spun out its OTC version to Unbuzzd Wellness Inc., retaining a 20.11% ownership stake and royalty payments of 7% of sales until $250 million is reached, after which the royalty drops to 3% in perpetuity.
The company maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property. This diversification provides additional financial stability as the company progresses its clinical programs.
The successful completion of these studies represents a significant derisking event for Quantum BioPharma. It paves the way for the IND submission and subsequent Phase 2 trials, potentially bringing a new treatment option to patients with multiple sclerosis who currently have limited therapeutic choices. The implications for the multiple sclerosis community are substantial, as Lucid-MS targets remyelination, a mechanism that could address the underlying disease progression rather than just symptoms.
For more information, visit the company’s newsroom at https://ibn.fm/QNTM and the full press release at https://ibn.fm/HJ5wR.
