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March 28, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced data from toxicology studies evaluating OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program. In non-human primates and rodents, there were no drug-related findings in the toxicology assessments, including gross pathology, histopathology (still ongoing in the rodent), clinical signs and clinical chemistries. Omeros expects to submit a European Clinical Trial Application (CTA) in the second quarter of this year to initiate clinical trials evaluating OMS721.
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, or the acquired immune response to infection. The Company has conducted a series of
in vivo studies that suggest that MASP-2 inhibition may have a preventive or therapeutic effect in the treatment of atypical hemolytic uremic syndrome (aHUS), HUS, wet age-related macular degeneration (AMD), paroxysmal nocturnal hemoglobinuria (PNH), transplant-related complications, ischemia-reperfusion injury, and other immune-related disorders.
The studies reported today in both primates and rodents provide the primary safety data expected to support the initiation of OMS721 clinical studies in mid-year 2013. The pharmacokinetic results in primates demonstrated that subcutaneous administration of OMS721 resulted in maximal inhibition of the lectin pathway within six hours of administration and maintained it for two or more weeks. In addition, the bioavailability and pharmacokinetics observed in both species are expected to support subcutaneous administration in patients at a frequency of once weekly, bi-monthly or possibly at even longer intervals. The only currently approved complement inhibitor requires an intravenous infusion lasting 30 minutes or longer in the hospital or doctor's office. Subcutaneous dosing avoids the complexity and inconvenience of intravenous infusion and would allow patients to self-administer OMS721 at home.