May 28, 2013
/PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has filed a Clinical Trial Application (CTA) with European regulators to initiate clinical trials evaluating OMS721, the Company's lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) program. The lead indication for OMS721 will be atypical hemolytic uremic syndrome (aHUS), a rare but life-threatening form of thrombotic microangiopathy (TMA). Assuming positive regulatory review of its CTA, Omeros plans to initiate a Phase 1 clinical trial evaluating OMS721 early next quarter.
The Phase 1 clinical trial will be a placebo-controlled, double-blind, single-ascending-dose study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered subcutaneously in healthy subjects. Immediately following this study, Omeros plans to advance OMS721 into a Phase 2 clinical trial in aHUS patients.
Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein involved in activation of the complement system – an important component of the immune system. The complement system plays a role in the inflammatory response to tissue damage or microbial infection. OMS721 selectively inhibits MASP-2, blocking the lectin pathway of the complement system while leaving intact the classical pathway, which represents the acquired immune response to infection. Soliris
(eculizumab), the only approved complement-targeting antibody on the market and the only currently approved therapy for aHUS, inhibits microbial killing by the classical pathway, increasing the risk of infection for the patient. By targeting only the lectin pathway and leaving the classical pathway intact, OMS721 should not have this increased infection risk. In addition, Soliris requires a 20-minute to 2-hour intravenous infusion in a medical facility, while OMS721 is designed to be self-administered by subcutaneous injection, which would be more convenient for patients.
Omeros' previously reported findings indicate that blockade of MASP-2 by OMS721 may have a preventive or therapeutic effect in the treatment of aHUS and other life-threatening TMAs, such as hemolytic uremic syndrome and thrombotic thrombocytopenic purpura, as well as a wide range of additional disorders, including paroxysmal nocturnal hemoglobinuria, age-related macular degeneration, ischemia-reperfusion injury and transplant-related complications.