Omeros: Narsoplimab results ‘not what we expected’ for treating proteinuria, ends trial
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Key takeaways:
- Results from the ARTEMIS-IGAN phase 3 trial of narsoplimab showed a lower-than-expected reduction in proteinuria.
- Omeros said the drug was well tolerated and there were no safety signals of concern.
An interim analysis of outcomes from a phase 3 trial evaluating narsoplimab for the treatment of immunoglobulin A nephropathy showed the reduction in proteinuria from baseline did not reach statistical significance compared with placebo.
Omeros Corporation said in an earnings call to investors that based on the analysis, it would discontinue the trial.
“Obviously, the results were not what we expected,” Jonathan Barratt, PhD, FRCP, an investigator in the ARTEMIS-IGAN trial and Mayer professor of renal medicine and honorary consultant nephrologist at the University of Leicester, U.K., said during the call.
Barratt said the proteinuria reduction in the placebo group of the trial was substantially greater compared with other immunoglobulin A (IgA) nephropathy clinical trials. “What we saw in the placebo arm of this study is inconsistent with what we believe to be the natural history of IgA nephropathy,” he said.
Barratt said the high proteinuria reduction in the placebo group was not seen in phase 2 of the trial.
The primary endpoint was a reduction in proteinuria assessed by 24-hour urine protein excretion (UPE) at 36 weeks compared with placebo in the intent-to-treat population of 180 patients with IgA nephropathy with high baseline proteinuria (24-hour UPE > 2 g/day).
“We will conduct more detailed analyses of the data to understand better the outsized placebo effect and the overall trial results, and to try to identify useful biomarkers,” Gregory A. Demopulos, MD, chairman and CEO of Omeros, said in a press release.
“Based on the absence of statistical significance and as previously agreed with FDA, Omeros will not submit an application for approval of narsoplimab in this indication and will discontinue the ARTEMIS-IGAN clinical trial,” he said.
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