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news.Eli Lilly and Company's tabalumab has failed to meet efficacy objectives in an interim futility analysis of FLEX-M study conducted in rheumatoid arthritis patients.
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The termination of one of three Phase 3 rheumatoid arthritis registration studies of the anti-BAFF monoclonal antibody is not due to safety concerns and patients presently enrolled in other tabalumab RA studies will continue treatment.
Lilly autoimmune product development vice president Eiry Roberts said the study results were unexpected compared to earlier results from Phase II clinical studies of tabalumab.
"We remain committed to patients with rheumatoid arthritis and lupus and will move rapidly to evaluate the impact of these data on the overall tabalumab clinical development programme," Roberts added.
"Beyond tabalumab, Lilly will continue to develop additional treatment options for patients with autoimmune diseases."
Eli Lilly will continue the evaluation of the candidate in two other Phase 3 RA registration studies besides an open-label extension study and other smaller studies.