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[HEALTH] · United States · 2 sources

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Quantum Biopharma receives FDA clearance for MS myelin-repair drug trial

Quantum Biopharma Ltd. has received FDA clearance to begin phase two clinical trials for Lucid-MS, a drug designed to protect and repair the myelin sheath in patients with multiple sclerosis (MS). Unlike current treatments that focus on suppressing the immune system to prevent attacks, this investigational medicine aims to address nerve damage directly. Medical experts note that while this represents a significant shift in research toward myelin-repair therapy, it is a scientific milestone rather than a proven cure, and its ability to reverse existing disability remains uncertain.

In a separate study published in Neurology, researchers examined the efficacy of early MS treatments among 509 newly diagnosed individuals. The findings indicated that B-cell–depleting infusion therapies were associated with lower relapse rates and reduced MRI lesion volume compared to oral platform treatments over a two-year period. However, the study found no significant differences in disability scores or blood signs of nerve damage between the various treatment groups after two years.

Entities

American Academy of Neurology · FDA · Karolinska Institutet · Quantum BioPharma Ltd.