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
- Proteinuria reduction in the placebo group was substantially greater than reported in other IgA nephropathy clinical trials
Webcast conference call planned for
8:30 a.m. ETtoday
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.
“We want to thank all the patients and investigators who participated in the trial,” said
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.
Conference Call Details
Omeros’ management will host a conference call and webcast to discuss the results. The call will be held today at
For online access to the live webcast of the conference call, go to Omeros’ website at https://investor.omeros.com/upcoming-events.
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A replay of the call will be made accessible online at https://investor.omeros.com/archived-events.
Omeros is an innovative 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. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including COVID-19. Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 clinical trial. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing across multiple clinical programs for alternative pathway-related diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and complement 3 (C3) glomerulopathy. For more information about Omeros and its programs, visit www.omeros.com.
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