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Omeros Announces Toxicology Data that Support Advancing MASP-2 Inhibitor into Clinical Trials
Date:3/28/2013

SEATTLE, 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
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