Biogen Idec Inc. announced on October 9th that it was discontinuing development of its investigational rheumatoid arthritis (RA) drug baminercept after it failed to meet Phase II study endpoints.
Baminercept was being investigated for use in RA patients who did not respond to treatment with conventional disease modifying anti-rheumatic drugs (DMARD), such as methotrexate. The primary endpoint was the measurement of patients who achieved a 50% improvement in the number of swollen, tender joints, as well as other clinical measures at week 14.
The secondary endpoints were defined as the proportion of patients with a 20% improvement and a 70% improvement in the number of swollen and tender joints as well as other quality of life measures.
The first Phase II study, known as 104RA202, included 380 patients with active rheumatoid arthritis did not have and adequate response to conventional DMARD therapy. This was a double-blind, placebo-controlled, multicenter trial designed to assess the efficacy of 5 different dosages of baminercept in combination with methotrexate over a 12 week period.
The second Phase II study, known as 104RA203, included about 120 patients with active RA that did not have an adequate response to tumor necrosis factor (TNF) inhibitors. This was also a randomized, double-blind, placebo-controlled, multicenter trial. It was designed to assess the efficacy of a 200 mg dose of baminercept over a 12 week period in combination with methotrexate.
Based on the results of these 2 trials, Biogen has decided to discontinue development of baminercept for treating rheumatoid arthritis. However, the company indicated that baminercept did have potential uses for treating other inflammatory diseases, such as Crohn’s disease and multiple sclerosis. As of now, there are no clinical trials scheduled for these conditions.