Omeros Files IND Application With FDA To Initiate Phase 2 For OMS721

(RTTNews) - Omeros Corp. (OMER), a clinical-stage biopharmaceutical company focused on small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system, Tuesday said it has submitted a investigational new drug, or IND, application to the U.S. Food and Drug Administration to initiate Phase 2 clinical program for OMS721, a drug meant for treating thrombotic microangiopathies, a family of orphan disorders, including atypical hemolytic uremic syndrome and thrombotic thrombocytopenic purpura,

These disorders occur in the microcirculation of the body's organs, most commonly the kidney and brain.

OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a regulator of the lectin pathway of the immune system.

In February, OMEROS announced the completion of dosing of OMS721 in Phase 1 clinical trail, where the drug was, the company reports, well tolerated and achieved a high degree of sustained lectin pathway inhibition, consistent with the efficacy of the drug seen in animal models of thrombotic microangiopathies (TMA), age-related macular degeneration and other lectin pathway-related disorders.

Enrollment into the Phase 2 clinical trial is expected to begin after the FDA's clearance of the IND.