Quantum BioPharma Ltd. (NASDAQ: QNTM) submitted an Investigational New Drug application to the U.S. Food and Drug Administration for its multiple sclerosis treatment candidate Lucid-21-302, according to a company statement.

The Toronto-based biopharmaceutical company plans to initiate a Phase 2 clinical trial evaluating the drug's efficacy, safety, and tolerability in multiple sclerosis patients, pending FDA clearance expected in the second quarter of 2026.

The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information. Lucid-MS completed Phase 1 clinical trials, where it demonstrated what the company described as a favorable safety profile and was well-tolerated in healthy participants.

The drug candidate targets demyelination, a process where protective sheaths around nerve fibers are damaged, which the company states is a key driver of disease progression in multiple sclerosis. According to the press release, this approach differs from many existing therapies that primarily focus on modulating the immune system.

"This IND submission is supported by a comprehensive preclinical research package designed to characterize the safety profile of Lucid-MS and support its evaluation in patients," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum BioPharma.

Multiple sclerosis affects approximately 2.8 million people worldwide, according to data cited by the company from the Atlas of MS, Third Edition. The company projects Phase 2 interim data availability in the fourth quarter of 2026.

Quantum BioPharma also operates through subsidiaries including Lucid Psycheceuticals Inc., which focuses on Lucid-MS development, and maintains a 19.84% ownership stake in Unbuzzd Wellness Inc., which markets a consumer product called UNBUZZD.