Quantum BioPharma Completes Key Toxicity Studies for Multiple Sclerosis Treatment Candidate

Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) has completed oral dosing in both 180-day chronic toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS), representing a significant milestone in the development pathway for this potential multiple sclerosis treatment. The completion of these studies supports the company's planned Investigational New Drug application with the U.S. Food and Drug Administration, moving the program closer to clinical-stage development for this first-in-class therapeutic candidate. These toxicity studies are specifically intended to support the design and advancement of a Phase 2 clinical trial of Lucid-MS in people with multiple sclerosis, addressing a critical need for new treatment options in the neurodegenerative disease space.

The importance of this development lies in the potential of Lucid-MS to address the underlying mechanism of multiple sclerosis through its patented new chemical entity shown to prevent and reverse myelin degradation in preclinical models. Myelin degradation represents the fundamental pathological process in multiple sclerosis, and a treatment capable of addressing this mechanism directly could represent a significant advancement over current symptomatic treatments. The completion of these extended toxicity studies provides essential safety data required by regulatory authorities before human trials can proceed, demonstrating the compound's safety profile over an extended dosing period that mirrors potential long-term treatment scenarios.

This milestone positions Quantum BioPharma to advance its lead compound toward clinical evaluation, with the company maintaining a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc. The company's broader focus includes 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., Quantum BioPharma continues to focus on the research and development of Lucid-MS as its primary therapeutic candidate.

The advancement of Lucid-MS through these critical preclinical studies represents progress toward addressing a significant unmet medical need in the multiple sclerosis treatment landscape. Multiple sclerosis affects approximately 2.8 million people worldwide, with current treatments primarily focusing on managing symptoms and slowing disease progression rather than addressing the underlying myelin degradation. The potential for a first-in-class therapeutic that directly targets myelin preservation and restoration could fundamentally change treatment paradigms for this chronic neurological condition. Further information about the company's developments is available through its newsroom at https://ibn.fm/QNTM, while the full details of this announcement can be accessed at https://ibn.fm/HJ5wR.