The trial compared experimental drug alemtuzumab with approved multiple sclerosis (MS) drug Rebif which showed 55% reduction in relapse rate in 2 annual cycles of alemtuzumab treatment as compared to Rebif over two years of the study
Sanofi and its subsidiary Genzyme have involved around 581 patients in the trial who had not previously received treatment to suppress MS, except steroids.
The 2-year comparative study demonstrated that 8% of alemtuzumab treated patients had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) as compared to 11% of those who received Rebif.
Currently, the companies are pursuing another Phase 3 CARE-MS II trial comparing alemtuzumab against Rebif in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy.
Sanofi CEO Christopher Viehbacher said in this 2-year comparative study, the effect of alemtuzumab on reducing relapses versus Rebif is impressive, and the safety profile is consistent with the Phase 2 clinical trial experience.
"We look forward to the results from CARE-MS II, which will provide clinical data in patients whose disease was not adequately controlled on other multiple sclerosis therapies," Viehbacher said.