Biogen Idec (CAMBRIDGE, Massachusetts) announced that its phase II trial of baminercept (LTßR-Ig or BG9924) in rheumatoid arthritis (RA) patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug did not meet its primary endpoint defined as the proportion of baminercept-treated patients who achieved an ACR50 response compared with placebo at 14 weeks. The study also did not meet any of the prespecified secondary endpoints defined as the proportion of patients who achieved scores of ACR20 and ACR70, improvement in DAS scores, and accepted tools to evaluate improvements in quality of life. Biogen will continue to analyze the trial results and will submit the data for presentation at an upcoming medical meeting.

The 104RA202 study was a phase II randomized, double-blind, placebo-controlled, multicenter, dose-finding trial designed to assess the efficacy of five different regimens of baminercept when administered over 12 weeks in combination with methotrexate within the patient population. The 104RA203 study also was a phase II randomized, double-blind, placebo-controlled, multicenter trial. Approximately 120 RA patients were to be enrolled in that trial, which was designed to assess the efficacy of 200 mg dose of baminercept administered over 12 weeks in combination with methotrexate.

The safety data to date, including incidence of overall adverse events, serious adverse events and infections, suggest that baminercept was well tolerated. However, based on the trial results as well as preliminary data, the company has decided to discontinue the development of the compound in RA. Baminercept was the first dual-mechanism lymphotoxin-β (LT-β) and LIGHT pathway inhibitor in development for the treatment of autoimmune diseases.