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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