The nine-month phase II study of 90 patients with relapsing-remitting multiple sclerosis (RRMS) compared a 40 mg dose of Copaxone to the currently approved 20 mg dose. Brain imaging showed participants on the higher dosage experienced on average a 38% greater reduction in brain lesions than those taking the 20 mg dose.
In addition, patients taking Copaxone 40 mg experienced a reduced average on-trial relapse rate of 77% as compared to 62% with Copaxone 20 mg.
“These results suggest that a 40 mg dose of Copaxone may provide even better control of disease activity within the central nervous system than the currently approved 20 mg dose,” said Jeffrey Cohen, director of the experimental therapeutics program at the Cleveland Clinic’s Mellen Center for MS Treatment and Research and coordinating principal investigator of the study.
The study also demonstrated that Copaxone 40 mg was well-tolerated with a safety profile similar to the currently available 20 mg dose. Teva plans to launch a large-scale phase III study later in 2006 to confirm the safety and improved efficacy of the higher dose.
Copaxone (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in patients with RRMS. It is now approved in 44 countries worldwide, including the US, Canada, Mexico, Australia, Israel, and all European countries. Copaxone is jointly marketed by Teva and Sanofi-Aventis in Europe.