Quantum BioPharma Receives Positive Clinical Study Report for Lucid-MS

Quantum BioPharma Ltd. has received the clinical study report for a Phase 1 trial of its multiple sclerosis treatment, Lucid-MS. The report concludes that the compound is safe and tolerable in healthy participants. Lucid-MS is a non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis. It is a patented New Chemical Entity (NCE) that has shown promise in preclinical models.

Quantum BioPharma Ltd. (NASDAQ: QNTM) has received the clinical study report (CSR) for its Phase 1 Multiple Ascending Dose (MAD) trial of Lucid-MS, an experimental multiple sclerosis treatment. The CSR concludes that Lucid-MS demonstrated safety and tolerability in healthy participants following consecutive daily dosing.

Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound designed to prevent demyelination, a key characteristic of multiple sclerosis. The successful completion of this trial marks a crucial milestone, enabling Quantum BioPharma to proceed with its Investigational New Drug (IND) application to the FDA and advance toward efficacy trials in MS patients.

What sets Lucid-MS apart in the competitive MS treatment landscape is its novel mechanism of action. Unlike existing MS therapies that primarily target the immune system, Lucid-MS specifically aims to prevent demyelination – the degradation of the protective myelin sheath around nerve fibers that characterizes MS. This represents a fundamentally different approach to treating the disease.

The Phase 1 MAD results are particularly meaningful as they form a crucial component of the company's upcoming IND application with the FDA. With this safety data secured, Quantum BioPharma is now preparing to advance to efficacy trials in actual MS patients. For a first-in-class compound with a novel mechanism, clearing the initial safety hurdle without concerns provides validation for the continued development program.

As a patented New Chemical Entity (NCE) with promising preclinical data and now human safety confirmation, Lucid-MS represents a potentially valuable asset in Quantum BioPharma's neuropharmaceutical portfolio. The drug's progression from discovery through preclinical testing and now successful Phase 1 studies demonstrates the company's ability to advance novel compounds through the critical early stages of development.

References:
[1] https://www.stocktitan.net/news/QNTM/quantum-biopharma-announces-positive-results-of-the-clinical-study-882ql67w5496.html
[2] https://www.globenewswire.com/news-release/2025/08/05/3127241/0/en/Quantum-Biopharma-Announces-Positive-Results-of-the-Clinical-Study-Report-CSR-for-the-Phase-1-Multiple-Ascending-Dose-MAD-Clinical-Trial-of-Experimental-Multiple-Sclerosis-Drug-Luc.html