Omeros Corp. (OMER) announced data from toxicology studies evaluating OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 or MASP-2 program. In non-human primates and rodents, there were no drug-related findings in the toxicology assessments, including gross pathology, histopathology, clinical signs and clinical chemistries. Omeros expects to submit a European Clinical Trial Application or CTA in the second quarter of this year to begin trials assessing 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 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, transplant-related complications, ischemia-reperfusion injury, and other immune-related disorders.
The trials reported today in both primates and rodents provide the primary safety data expected to support the initiation of OMS721 studies in mid-year 2013.
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