Biogen Idec Inc. is stopping development of an investigational arthritis drug due to negative results from two studies that aimed to measure the drug's effectiveness. Both Phase II studies of baminercept in combination with methotrexate were designed to show an improvement in rheumatoid arthritis, and neither study hit the mark.
However, that was not the Cambridge, Mass.-based company's only development program in rheumatoid arthritis.
Its most advanced pipeline program in that disease is Phase III ocrelizumab, an anti-CD20 antibody like Rituxan, the company's approved product for rheumatoid arthritis (RA), Biogen spokeswoman Naomi Aoki said.
Phase II baminercept would have been the next most advanced program for that disease, while the company's other pipeline product for RA is preclinical, she said.
Although development of baminercept in rheumatoid arthritis has come to a halt, "the compound may have potential in other indications," Christopher Raymond, an analyst with Robert Baird & Co. wrote in a research note. He cited inflammatory diseases, Crohn's disease and multiple sclerosis as possible indications, though he said no clinical trials are planned at this time.
Biogen's Aoki confirmed that the company is exploring the possibility of developing baminercept in other indications, but said no decision has been made on specific diseases to target. However, she noted that the company has looked at other autoimmune diseases at the preclinical stage.
In the two studies of baminercept, the primary endpoint was the percent of baminercept-treated patients vs. placebo-treated who achieved a 50 percent improvement in swollen and tender joint counts and other clinical measures at week 14.
A 380-patient study evaluated different doses of a baminercept regimen in individuals who had not responded well to conventional therapy with a disease-modifying antirheumatic drug such as methotrexate. Other goals in that study also were not met, including 20 percent and 70 percent improvements in the disease.
Biogen Idec said it still is analyzing the results from that study and will present data at an upcoming medical meeting. Though it is too late to submit data for presentation at the America College of Rheumatology annual meeting later this month, ACR's counterpart in Europe, the European League Against Rheumatism (EULAR) holds its annual meeting next June.
Aoki said that while EULAR is a likely possibility, she could not say with certainty that baminercept study data would be presented at that meeting.