Genzyme, a Sanofi company (SNY), on Tuesday reported additional data from the Phase III CARE-MS II trial.
Accumulation of disability was significantly slowed in patients with multiple sclerosis who were treated with alemtuzumab versus Rebif, as measured by the Expanded Disability Status Scale, a standard assessment of physical disability progression.
In addition, significant improvement in disability scores was observed in some patients treated with alemtuzumab from baseline and compared to patients treated with Rebif, suggesting a reversal of disability in these patients. In the trial, patients with pre-existing disability treated with alemtuzumab were more than twice as likely to experience a sustained reduction in disability than patients given Rebif.
Genzyme is developing alemtuzumab in multiple sclerosis in collaboration with Bayer HealthCare.
CARE-MS II was a randomized Phase III clinical trial comparing the investigational drug alemtuzumab to Rebif in patients with relapsing-remitting multiple sclerosis who had relapsed while on prior therapy. The company announced in November that results for the co-primary endpoints of the trial were highly statistically significant. Additional new data from the CARE-MS II study suggest that alemtuzumab provided significant improvement over Rebif across a number of imaging endpoints, consistent with the effects observed in the clinical endpoints. The company said it is on track to file for U.S. and EU approval of alemtuzumab in relapsing multiple sclerosis in the second quarter of 2012.
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