Omeros Corporation provided an update regarding the interim analysis outcome in ARTEMIS-IGAN, the Company?s Phase 3 trial evaluating narsoplimab for the treatment of immunoglobulin A (IgA) nephropathy. The primary endpoint 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). Topline results show that narsoplimab did not achieve statistically significant improvement over placebo.

The UPE reduction in the placebo group was markedly greater than that reported in trials of other agents in IgA nephropathy. 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. Consistent with the safety profile observed in other narsoplimab studies, results from the interim analysis in ARTEMIS-IGAN indicate that narsoplimab has been generally well tolerated without any safety signal of concern.