Lilly has decided to call a halt to a phase III trial of its rheumatoid arthritis (RA) prospect tabalumab after an interim analysis suggested it would miss efficacy targets.
The trial, which was conducted in moderate-to-severe RA patients who had not responded to prior therapy with the disease-modifying anti-rheumatic drug (DMARD) methotrexat, is one of three pivotal studies Lilly is carrying out on the antibody.
The pharma company also said it would suspend enrolment in the two other phase III studies and an open-label extension study while it examines the data, but stressed there were no safety concerns with tabalumab.
Lilly will take a charge of around $20m to $35m in its fourth quarter results as a result of the decision to halt the study.
“The results of this study were unexpected given the data generated in earlier phase II clinical studies of tabalumab,” said Eiry Roberts, Lilly’s vice president of autoimmune product development.
“We will move rapidly to evaluate the impact of these data on the overall tabalumab clinical development programme,” she added.
Talamumab, also known as LY2127399, is an anti-B-cell activating factor (BAFF) human monoclonal antibody that is in development for RA as well as other autoimmune diseases such as systemic lupus erythematosus (SLE).
Lilly said its phase II trials in SLE will continue to enrol new patients as “there is no evidence to suggest that [the RA] efficacy results are indicative of potential efficacy in the lupus population”.
Tabalumab is one of several candidates in late-stage development at Lilly for autoimmune conditions, along with anti-IL-17 antibody ixekizumab for psoriasis and psoriatic arthritis, and baricitinib – a JAK1 and JAK2 inhibitor being developed in collaboration with Incyte for RA, psoriasis and diabetic nephropathy.
The company needs new products to come through the pipeline as it faces patent expiration on its big-selling antidepressant Cymbalta (duloxetine) from next year, but has had a string of disappointments of late with solanezumab for Alzheimer’s, Alimta (pemetrexed) in lung cancer and schizophrenia candidate pomaglumetad methionil.