UPE

Omeros Corporation Provides Update on Interim Analysis of ARTEMIS-IGAN Phase 3 Trial of Narsoplimab in IgA Nephropathy

Retrieved on: 
Monday, October 16, 2023
Health, Stem Cells, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Cancer, Biomarker, M.D, Placebo, PIN, Safety, UPE, FDA, Corporation, Immunoglobulin A, Proteinuria, Clinical trial, Patient, ARTEMIS, Pharmaceutical industry, Omeros, IgA nephropathy

Topline results show that narsoplimab did not achieve statistically significant improvement over placebo.

Key Points: 
  • 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 Gregory A. Demopulos, M.D, chairman and chief executive officer of Omeros.