Omeros Announces FDA Grants Fast Track Designation to Complement Inhibitor OMS721 for aHUS

Omeros Corporation

today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. Omeros is currently evaluating the drug in a Phase 2 clinical trial for the treatment of aHUS and other thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. Earlier this year, Omeros announced positive data from the Phase 2 trial and commencement of an investigator-requested compassionate use program for OMS721 to allow extended treatment of patients who completed the trial's four-week dosing. Recent efficacy and safety data from the ongoing Phase 2 clinical trial were submitted to the FDA in the company's request for Fast Track status for OMS721. FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have