Teva Pharmaceutical Industries Ltd. (TEVA: Quote) and Active Biotech AB (ATVBF) issued an update on the clinical development program of once-daily oral laquinimod for the treatment of relapsing-remitting multiple sclerosis, or RRMS.
The companies are to initiate a third Phase III study of laquinimod, following the written agreement reached with the U.S. Food and Drug Administration, or FDA, on the Special Protocol Assessment.
The third Phase III laquinimod trial CONCERTO will assess two doses of the investigational product (0.6mg and 1.2mg) in around 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale.
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by RTT Staff Writer
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