Tabalumab is an anti-B cell activating factor monoclonal antibody. BAFF is a cytokine that promotes the survival of B cells, which can contribute to the development of RA. Tabalumab inhibits BAFF. Lilly tested the antibody as a treatment for multiple autoimmune conditions.
The Phase III program for tabalumab for systemic lupus erythematosus, Illuminate, will continue as planned.
“While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas,” Eiry Roberts, Lilly’s vice president of autoimmune product development, said. “Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase 3 tabalumab lupus program.”
In December, Lilly discontinued its Phase III RA registration study Flex-M for lack of treatment effect. Flex-M investigated tabalumab in patients with moderate-to-severe RA with an inadequate response to methotrexate therapy. An interim futility analysis was conducted on the Flex-M findings and the Flex-V study, which investigated tabalumab for treatment of patients with moderate-to-severe RA with an inadequate response to one or more inhibitors of tumor necrosis factor.
Based on the two separate interim futility analyses, Lilly discontinued development of tabalumab in the current RA program, stopping all Phase II and Phase III RA studies. Lilly said that the decision was not based on safety concerns.
Indianapolis-based Lilly also has potential new medicines in clinical development for psoriasis and diabetic nephropathy.