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Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) announced that the U.S. Food and Drug Administration has approved its Investigational New Drug (“IND”) application for Lucid-MS (Lucid-21-302), clearing the company to advance the patented, first-in-class multiple sclerosis candidate into Phase 2 clinical development. The planned randomized, double-blind, placebo-controlled study will evaluate efficacy, safety and tolerability in people with MS using clinical and radiological measures. Trial start-up activities, including site selection, are underway, with patient enrollment and drug administration expected to begin as quickly as possible.
Lucid-MS is designed to provide neuroprotection by inhibiting demyelination, differentiating it from existing MS therapies that primarily focus on modulating the immune system. The candidate targets protein arginine deiminase 2 (“PAD2”), an enzyme implicated in myelin degradation, and has demonstrated the ability to prevent and reverse myelin breakdown in preclinical models. Quantum BioPharma said Lucid-MS demonstrated a favorable safety profile and was well tolerated in prior Phase 1 trials in healthy participants. The company reported more than $10 million in cash, digital assets and liquid investments as of March 31, 2026.
In brief
Quantum BioPharma Ltd. says the U.S. Food and Drug Administration has cleared its Lucid-MS candidate for Phase 2 development by approving the company’s Investigational New Drug application. The proposed trial will compare the treatment with placebo under blinded conditions and assess efficacy, safety and tolerability in people with multiple sclerosis, using clinical and imaging-based measures. The company reports that preparations, including choosing study sites, are in progress; enrollment and dosing are expected to start as soon as possible. Lucid-MS is intended to protect nerve cells by acting on PAD2, which the company associates with myelin damage. Quantum BioPharma also cites positive tolerability and safety findings from earlier Phase 1 testing in healthy participants, and reported more than $10 million in cash, digital assets and liquid investments at March 31, 2026.
Key takeaways
- FDA approval of the IND application allows Lucid-MS to move into Phase 2 development.
- The planned study will assess efficacy, safety and tolerability in people with multiple sclerosis.
- Site selection and other trial preparations are underway; enrollment and dosing are expected to follow.
- The company reported more than $10 million in cash, digital assets and liquid investments as of March 31, 2026.
To view the full press release, visit https://ibn.fm/HyWYH
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(TM) and spun out its OTC version to a company, Unbuzzd Wellness Inc. (“Unbuzzd”) (formerly, Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.84% (as of March 31, 2026) of Unbuzzd at www.unbuzzd.com. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd(TM) 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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Questions around this news
What does FDA clearance of an IND application mean?
An Investigational New Drug application is a request to begin testing an experimental medicine in people in the United States. FDA clearance allows the proposed clinical investigation to proceed, subject to applicable requirements. It is not a finding that the medicine is effective or approved for sale.
What will the planned Phase 2 study of Lucid-MS examine?
The company plans a randomized, double-blind, placebo-controlled study in people with multiple sclerosis. It is intended to assess efficacy, safety and tolerability through clinical and radiological measures. Site selection and other trial start-up work are underway; the company says enrollment and drug administration are expected to begin as quickly as possible.
How is Lucid-MS intended to work differently from existing MS therapies?
The company says Lucid-MS is designed to protect nerve cells by inhibiting demyelination, the breakdown of myelin. Its proposed target is PAD2, an enzyme implicated in myelin degradation. The release contrasts this approach with existing multiple sclerosis treatments that primarily act by modulating the immune system.
What safety information about Lucid-MS has been reported so far?
The company reports that Lucid-MS had a favorable safety profile and was well tolerated in earlier Phase 1 trials involving healthy participants. The planned Phase 2 study will further examine safety and tolerability, alongside efficacy, in people with multiple sclerosis. The release does not provide detailed Phase 1 results.
SEC filings
Earlier from Quantum BioPharma Ltd.
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Advances MS Imaging Study with Encouraging Preliminary Results
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Developing Two-Pronged Attack on Brain Disorders Affecting Millions
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Expands Clinical Development of Neuroprotective Therapy
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Advances Novel Multiple Sclerosis Therapy Toward Phase 2 Trials
- Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) Reports Midpoint Enrollment Milestone in MS Imaging Study
