Biogen Idec announced that its phase-II trial of baminercept (BG9924, LTßR-Ig) in rheumatoid arthritis (RA) patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug (DMARD) did not meet its primary endpoint. The primary endpoint was defined as the proportion of baminercept-treated patients who achieved an ACR50 response, a standard measure of disease improvement in RA, compared to placebo at 14 weeks. The study also did not meet any of the pre-specified secondary endpoints. Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
Based on these results as well as preliminary data from a phase-II trial of baminercept in RA patients who have had an inadequate response to a tumour necrosis factor (TNF) inhibitor, the company has decided to discontinue the development of the compound in RA.
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities.
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs.