October 2, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Eli Lilly and Company , headquartered in Indianapolis, announced today that it is ending its development of tabalumab, which was being studied for potential treatment of systemic lupus erythematosis (SLE). In two pivotal phase 3 trials the compound did not show sufficient efficacy. Safety was not an issue.
The drug was being tested in two studies, ILLUMINATE 1 and ILLUMINATE 2. In ILLUMINATE 1, the compound did not meet the primary endpoint for each dose studied, which was statistically significant improvement on SRI-5, a measurement of lupus activity and response. ILLUMINATE 2 was a bit more successful, with the higher dose of tabalumab meeting the endpoint. However, the two studies collectively did not meet expectations compared to existing treatments. As a result, Lilly has discontinued plans to submit to worldwide regulatory agencies.
“Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in one of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies,” said Lilly Bio-Medicines’ senior vice president J. Anthony Ware in a press release. “The ILLUMINATE trials are the largest phase 3 clinical studies in lupus to date, and we are hopeful that our contribution of the extensive data from these studies will advance knowledge to enhance treatment in this devastating illness. Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus.”
In December 2012 Lilly similarly announced that it was stopping a phase 3 clinical trial of tabalumab for rheumatoid arthritis due to insufficient efficacy. A follow-up announcement in February 2013 indicated the company was ending a related clinical study for the same reason.
Tabalumab is a fully human monoclonal antibody designed to at least partially neutralize membrane-bound and soluble B-cell activating factor (BAFF). BAFF is part of the family of tumor necrosis factor (TNF) and plays a significant role in the survival of peripheral B cells. The compound is being investigated for a number of possible clinical actions, including in patients with multiple myeloma.
Lilly indicates it will take a $75 million research-and-development charge in Q3 2014 that will reflect the pipeline setback. In early 2013 it took a similar $50 million charge when it dropped the rheumatoid arthritis studies. The company currently has seven compounds in phase 3 trials, including ixekizumab for psoriasis. The company announced announced in late August that ixekizumab met all primary and key secondary objectives in three pivotal trials of 3,866 patients with moderate-to-severe plaque psoriasis.
