(Reuters) – Eli Lilly and Co said it will stop one of three late-stage trials of its rheumatoid arthritis (RA) drug tabalumab due to insufficient efficacy.
The decision to stop the trial came after an interim futility analysis of the study, called FLEX-M.
The trial was testing the drug in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy, which is a standard RA treatment.
The decision was not based on safety concerns, and patients currently enrolled in other tabalumab RA studies will continue treatment, Lilly said.
However, the company said it was suspending enrollment of new patients in the RA program until additional analysis from other ongoing RA studies is completed in early 2013.
The study discontinuation is expected to result in an after-tax charge of about 2 cents per share in the fourth quarter.
“The results of this study were unexpected given the data generated in earlier Phase II clinical studies of tabalumab,” Lilly’s vice president of autoimmune product development, Eiry Roberts, said.
Lilly is working on another RA drug called baricitinib, which is also getting tested for psoriasis and diabetic nephropathy.
Another autoimmune disorder drug in the company’s pipeline is ixekizumab — being tested for psoriasis and psoriatic arthritis.
(Reporting by Esha Dey in Bangalore; Editing by Joyjeet Das)
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Lilly stops rheumatoid arthritis trial for lack of efficacy
