Breakthrough Status for Omeros Monoclonal Antibody

FDA has granted Omeros Corp. a breakthrough therapy designation for OMS721 for treating immunoglobulin A (IgA) nephropathy. The monoclonal antibody is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the “effector enzyme of the lectin pathway of the complement system,” according to the company. The designation was granted based on data from Omeros’ Phase 2 clinical trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases. The data show significant improvement in proteinuria following 12 weeks of treatment, with a 77% mean reduction in urine albumin-to-creatinine ratios and a 73% mean reduction in 24-hour urine protein levels, Omeros says. Proteinuria is an important marker for disease progression in patients with IgA nephropathy, and improvement in proteinuria is associated with improved clinical outcomes.