Sanofi and its subsidiary, Genzyme, announced positive results from Care-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (RRMS).
Genzyme is developing alemtuzumab in MS in collaboration with Bayer HealthCare.
In the Care-MS I trial, 2 annual cycles of alemtuzumab treatment resulted in a 55% reduction in relapse rate compared to Rebif over the two years of the study, satisfying the first primary endpoint and meeting the predefined protocol criteria for declaring the study a success.
Statistical significance was not achieved for the second primary endpoint, time to six-month sustained accumulation of disability, as compared to Rebif. At the two-year time point, 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. The patients will have the option to be evaluated over the next three years as part of a separate protocol.
“The substantial effect of alemtuzumab on reduction of relapse rate over and above that seen with Rebif confirms our experience gathered over many years and demonstrated in the Phase 2 study,” says professor Alastair Compston, chair of the steering committee overseeing the conduct of the study, and head of the department of clinical neurosciences at the University of Cambridge. “We treated patients in Care-MS I at a very early stage in the course of their illness when the natural history may be relatively quiet, and both groups were remarkably stable over the two years of observation. Very few patients accumulated disability at the rate expected from previous clinical trials, including our Phase 2 experience. Whilst welcome from the clinical perspective, this much reduced our ability to detect a significant treatment effect on the disability endpoint.”
CARE-MS I, which enrolled 581 early, active RRMS patients who had received no prior MS therapy, was a global, randomized, rater-blinded clinical trial to determine the efficacy and safety of alemtuzumab in this population.
The company expects to file for U.S. and E.U. approval of alemtuzumab in MS in early 2012, and has been granted fast track designation by the FDA.
Release Date: July 11, 2011
Filed Under: Drug Discovery