Posted by Michael Wonder on 14 Jun 2017
FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of IgA nephropathy
13 June 2017 - Omeros’ second Phase 3 clinical program for OMS721 slated to begin this year.
Omeros Corporation today announced that the US FDA has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
The data were recently presented at the 54th European Renal Association-European Dialysis and Transplant Association Congress in Madrid. Proteinuria is an important marker for disease progression in patients with IgA nephropathy, and improvement in proteinuria is associated with improved clinical outcomes.
The clinical trial data show unprecedented improvement in proteinuria following only 12 weeks of OMS721 treatment, with a 77% mean reduction in urine albumin-to-creatinine ratios (p = 0.026) and a 73% mean reduction in 24 hour urine protein levels (p = 0.013). In response, many physicians attending the conference in Madrid and representing centers across Europe, the U.S. and Asia that manage large numbers of IgA nephropathy patients asked to participate in Omeros’ planned Phase 3 clinical trial. These physicians have been added to the ongoing clinical site evaluation for the Phase 3 clinical program.
