Omeros' OMS721 Gets Orphan Drug Status From FDA - Quick Facts

(RTTNews) - Omeros Corp. (OMER) Wednesday said that OMS721 received orphan drug designation from the U.S. Food and Drug Administration or FDA for the prevention of complement-mediated thrombotic microangiopathies. OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, the key regulator of the lectin pathway of the immune system.

Omeros is completing a Phase 1 trial to study the safety and pharmacokinetics of OMS721. The company expects to report additional Phase 1 clinical data in early 2014. The Phase 2 clinical study evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in 2014 first quarter. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

Gregory Demopulos, chairman and chief executive officer of Omeros said: "This month we will initiate our OMS824 Phase 2 clinical program in Huntington's disease - earlier granted orphan drug designation by the FDA - and could also report Phase 2a data for OMS824 in schizophrenia. We then look to the potential marketing approval of Omidria, its launch completing our transition to a commercial company."