Sanofi today announced positive data from the Phase III FOCUS study, which evaluated the efficacy and safety of its investigational drug frexalimab in treating relapsing-remitting multiple sclerosis (RRMS).
The FOCUS study met its primary endpoint, showing that frexalimab significantly reduced the annualized relapse rate (ARR) compared to placebo. Frexalimab also showed a statistically significant improvement in disability progression, as measured by the Expanded Disability Status Scale (EDSS), and a clinically meaningful improvement in the number of new or worsening T2 lesions on MRI scans.
"These positive results from the FOCUS study are encouraging and support the potential of frexalimab as a new treatment option for people with RRMS," said Olivier Charmeil, Sanofi's Chief Medical Officer. "We look forward to sharing these data with regulatory authorities around the world."
Frexalimab is a humanized monoclonal antibody that targets CD20, a protein expressed on the surface of B cells. B cells are thought to play a role in the development of MS. Frexalimab is being developed as a once-monthly subcutaneous injection.
The FOCUS study was a randomized, double-blind, placebo-controlled trial that enrolled 1,043 patients with RRMS. Patients were treated with either frexalimab 600 milligrams (mg) or placebo once monthly for 24 weeks. The primary endpoint of the study was the ARR at week 24.
Frexalimab significantly reduced the ARR compared to placebo, with a hazard ratio (HR) of 0.46 (95% confidence interval [CI], 0.33-0.64; p<0.0001). Frexalimab also showed a statistically significant improvement in disability progression, as measured by the EDSS, with a mean change from baseline of -0.23 (95% CI, -0.39 to -0.07; p=0.003). In addition, frexalimab showed a clinically meaningful improvement in the number of new or worsening T2 lesions on MRI scans, with a mean change from baseline of -0.83 (95% CI, -1.41 to -0.25; p=0.004).
The safety profile of frexalimab was generally consistent with that seen in other studies of anti-CD20 antibodies. The most common adverse events (AEs) were upper respiratory tract infections, nasopharyngitis, and headache. Serious AEs occurred in 5.3% of patients treated with frexalimab and 5.1% of patients treated with placebo. There were no deaths in the study.
The FOCUS study results support the potential of frexalimab as a new treatment option for people with RRMS. Frexalimab is currently under review by regulatory authorities around the world.
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