Eli Lilly and Company has announced the termination of its Phase III rheumatoid arthritis (RA) programme for tabalumab based on negative efficacy results.
Tabalumab is an anti-BAFF (B cell activating factor) monoclonal antibody, which failed to demonstrate efficacy for the treatment of RA.
The termination was not due to safety issues and ILLUMINATE, a tabalumab Phase III programme for systemic lupus erythematosus, is ongoing and will continue as scheduled.
Lilly autoimmune product development vice president Dr Eiry Roberts said the company is disappointed by the results in rheumatoid arthritis but believes that tabalumab could be beneficial for patients with other diseases.
"Autoimmune disorders are highly individualised. 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 III tabalumab lupus program," Roberts said.
In December 2012, Lilly discontinued Phase III RA registration study FLEX-M, evaluating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy due to lack of efficacy.
Based on the FLEX-M results, the company conducted an interim futility analysis of the FLEX-V study.
FLEX-V study is a Phase III, multicentre, randomised trial designed to assess the efficacy and safety of tabalumab in patients with moderate-to-severe RA who had an inadequate response to one or more tumour necrosis factor inhibitors.
After concluding the two separate interim futility analyses, the company made the decision to discontinue tabalumab development in the current RA programme.
All ongoing Phase II and Phase III RA studies will be terminated.
Image: Eli Lilly’s global headquarters in Indianapolis, Indiana, the US. The company has terminated RA trials of tabalumab due to poor efficacy results.