Trials of tabalumab showed "insufficient efficacy."
After two trials showed “insufficient efficacy,” Eli Lilly and Company announced it is stopping development on tabalumab, a drug meant to treat patients with lupus.
A statement from the company said that during the ILLUMINATE 1 study the drug “did not achieve the primary endpoint, at either dose studied, of statistically significant improvement on SRI-5,” which is a measure of the disease’s activity. While the endpoint was reached during the ILLUMINATE 2 study with a higher dosage the company said, “The data from these studies did not meet expectations for efficacy in the context of existing treatments.”
During the studies the drug had a safety profile similar to current standard care options. The statement said as a result Lilly researchers will stop their work with the drug, including seeking approval from the various global regulatory entities.
“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 J. Anthony Ware, MD, Senior Vice President,
Product Development, Lilly Bio-Medicines.
Ware said that while work on the drug will stop, “Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus.”