FDA Clears Omeros' IND To Evaluate OMS721 In Thrombotic Microangiopathies

(RTTNews) - Omeros Corp. (OMER) announced its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement-mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. FDA.

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.

Gregory Demopulos, CEO of Omeros, said: "FDA's decision clears the way for us to begin the Phase 2 program for OMS721. We are excited by the data in serum samples from aHUS patients, and we look forward to reporting results from our Phase 2 clinical trial in patients with aHUS and other TMAs later this year."

The OMS721 Phase 2 clinical trial, planned to begin later current quarter, will evaluate the effects of the drug on patients with TMAs, including atypical hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, and stem cell transplant-related TMA.