Omeros Reports Final Efficacy and Safety Data from the Narsoplimab Pivotal Trial in HSCT-TMA – Argus Press


Omeros Corporation (Nasdaq: OMER) today announced final data from its pivotal trial for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), an often-lethal complication of stem-cell transplantation for which there is no approved therapy. Narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway and activator of the coagulation cascade, is being studied for the treatment of HSCT-TMA patients at high risk for poor outcomes. Narsoplimab has been awarded Breakthrough Therapy designation by U.S. FDA and is the subject of a rolling Biologics License Application (BLA) for HSCT-TMA. The nonclinical and CMC modules of the rolling BLA have already been submitted, and the final sections of the clinical module are in the publishing phase during which finalized documents are electronically processed and integrated for submission in the format required by FDA.

Omeros previously presented preliminary data from its pivotal HSCT-TMA trial.