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Frexalimab Data Boosts Progressive MS Hopes
22 Apr
Summary
- Three-year data shows frexalimab maintained near-zero lesions.
- Drug kept 86% of participants relapse-free for three years.
- Frexalimab showed no new safety signals over three years.
Sanofi presented three-year data for its investigational multiple sclerosis drug, frexalimab, on April 20 at the American Academy of Neurology 2026 Annual Meeting. The open-label extension of a Phase II study revealed that frexalimab significantly suppressed new MRI lesions, with Gadolinium-enhancing T1 lesions remaining at nearly zero throughout the three-year follow-up.
Efficacy results were strong, with 86% of participants in one arm remaining relapse-free over three years and showing stable Expanded Disability Status Scale scores. Safety data was also favorable, reporting no deaths or emerging safety signals, and maintaining stable lymphocyte and immunoglobulin levels, contrasting with some existing therapies.
Biomarker data, including reductions in neurofilament light chain and CXCL13, indicated neuroprotection and suppressed B-cell inflammation. Frexalimab also demonstrated slow rates of brain volume loss, particularly in the thalamus, a key indicator of neurodegeneration.
These positive outcomes from the Phase II study support ongoing Phase III trials for both relapsing and non-relapsing secondary progressive multiple sclerosis. The data suggests frexalimab could offer a unique, high-efficacy option for progressive MS patients, potentially addressing a significant unmet need.
