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Home » FDA Accepts IND for Monoclonal Antibody in Thrombotic Microangiopathies
FDA Accepts IND for Monoclonal Antibody in Thrombotic Microangiopathies
The FDA has accepted Omeros’ investigational new drug application for human monoclonal antibody OMS721 in complement-mediated thrombotic microangiopathies, the Seattle company announced Thursday. The candidate received orphan drug status last year.
Omeros plans to initiate a Phase II safety and efficacy study later this quarter. The study will evaluate OMS721 in patients with TMAs including atypical hemolytic uremic syndrome, thrombotic thrombocytopenia purpura and stem cell transplant-related TMA.
OMS721 works by inhibiting MASP-2, a pro-inflammatory protein involved in activating part of the immune system and blocking the lectin pathway, according to Omeros. The drugmaker controls the global rights to all therapeutics targeting MASP-2.
Omeros has a total of 12 programs in its pipeline, focusing on G-protein coupled receptors, the central nervous system, coagulopathies, antibodies and inflammation, among others. The company has already submitted a new drug application for Omidria, used in intraocular lens replacement surgery. — Lena Freund
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