Omeros Corporation (OMER)

[surf1944]

7:03AM Omeros announces FDA granted orphan drug designation to co's OMS721 for complement-mediated thrombotic microangiopathies (OMER) 8.92 :

Co announced that OMS721, its 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, has received orphan drug designation from the FDA for prevention of complement-mediated thrombotic microangiopathies (TMAs).
Co is completing a Phase 1 study to assess the safety and pharmacokinetics of OMS721. As previously announced, at the highest subcutaneous dose administered to date in this study, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase 1 subjects are similar to those associated with efficacy in animal models of diseases, including TMA, linked to the lectin pathway. Co expects to report additional Phase 1 clinical data in early 2014. The Phase 2 clinical program evaluating OMS721 for the prevention of complement-mediated TMAs is expected to begin in the first quarter of 2014.