Teva has started a major new clinical trial of its multiple sclerosis drug Copaxone (glatiramer acetate) aimed at confirming the benefits of hiking its daily dose.
Copaxone (glatiramer acetate) is approved as a 20mg dose, but the Israeli drugmaker recently reported Phase II results indicating that raising the dose to 40mg/day provides additional efficacy benefits in terms of reducing relapses and remains well-tolerated.
If positive, the results of the new study, called FORTE, could lend further sales momentum to Copaxone, which advanced 29% to $329 million in the first quarter of this year and is leading the US market for MS drugs.
The Phase II study found a 38% greater reduction in MS lesions as measured by magnetic resonance images (MRI) of the brain in patients taking the higher dose compared with those taking 20mg/day. In addition, patients taking 40mg saw a reduction of 77% in their annual average relapse rate, when compared to the years preceding enrollment into the study. For the lower dose the reduction was 62%.
FORTE will enroll around 1,000 patients in North America, Europe, Israel and Argentina, and is expected to generate results in 2008.