Omeros Discontinues Narsoplimab Development

Omeros says it is discontinuing its development of narsoplimab for treating immunoglobulin A (IgA) nephropathy based on Phase 3 clinical trial (ARTEMIS-IGAN) data that did not show statistical significance. An interim analysis of the ARTEMIS-IGAN trial failed to show a “statistically significant improvement over placebo,” the company says.

The primary endpoint in the study is reduction in proteinuria assessed by 24-hour urine protein excretion (UPE) at 36 weeks compared to placebo in the intent-to-treat population of 180 IgA nephropathy patients with high baseline proteinuria (24-hour UPE > 2 g/day). “The UPE reduction in the placebo group was markedly greater than that reported in trials of other agents in IgA nephropathy,” Omeros says. “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.”