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Omeros Corporation Provides Update on Interim Analysis of ARTEMIS-IGAN Phase 3 Trial of Narsoplimab in IgA Nephropathy
The ARTEMIS-IGAN trial did not reach statistical significance on the primary endpoint of reduction in proteinuria from baseline compared to placebo
About this update from Omeros Corporation
[{"type":"text","content":"\n\nThe ARTEMIS-IGAN trial did not reach statistical significance on the primary endpoint of reduction in proteinuria from baseline compared to placebo\n\n\n\n\nProteinuria reduction in the placebo group was substantially greater than reported in other IgA nephropathy clinical trials\n\n\n\n\nWebcast conference call planned for 8:30 a.m. ET today\n\n\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today 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.\n\n\nThe 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.\n\n\n“We want to thank all the patients and investigators who participated in the trial,” said Gregory A. Demopulos, M.D, chairman and chief executive officer of Omeros. “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. The funds earmarked for commercialization in IgAN and continuation of the ARTEMIS-IGAN trial will be redirected to our other later-stage programs, including our ongoing Phase 2 and upcoming Phase 3 programs for our alternative pathway inhibitor OMS906. In addition, our near-term focus remains the planned resubmission of our biologics license application for narsoplimab in hematopoietic stem-cell transp...