Eli Lilly has suffered a setback with the failure of its experimental rheumatoid arthritis drug tabalumab, which has failed to show efficacy in late-stage trials.
An indication that all was not as hoped came at the end of last year, when the group announced that it was stopping one of three Phase III clinical trials of the drug because it failed to show efficacy in patients with moderate-to-severe RA who had an inadequate response to methotrexate.
The data prompted an interim futility analysis of the other Phase III trials, based on which Lilly has decided to discontinue development of the anti-B cell activating factor (BAFF) monoclonal antibody in the RA programme.
Lilly will no doubt be disappointed with the news, particularly as it is battling generic competition to its five-billion-dollar a year antipsychotic Zyprexa (olanzapine) and is pinning its hopes on new treatments to fill the gaps as they emerge.
But it seems there is hope for the drug yet. "We continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, vice president of autoimmune product development at Lilly, adding: "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."
The tabalumab Phase III program for systemic lupus erythematosus remains live and unaffected by the decision.
Lilly noted that the move to terminate the current RA program for the drug should trigger a first-quarter charge to research and development expense of around $50 million, but financial guidance for the year remains unchanged.