Feb. 7, 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. Based on the data from these nonhuman primate studies, OMS721 is expected to be delivered subcutaneously to patients at a convenient dosing schedule of weekly, bi-monthly or even less frequently. Omeros is now analyzing additional data and expects to submit, in the second quarter of this year, an Investigational New Drug (IND) Application or Clinical Trial Application (CTA) to the applicable regulatory body to initiate clinical trials evaluating OMS721.
MASP-2 is a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of 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 hemolytic uremic syndrome (HUS), atypical HUS (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), wet age-related macular degeneration (AMD), ischemia-reperfusion injury, transplant-related complications and other immune-related disorders.
The studies reported today demonstrated that, following subcutaneous administration, the plasma concentration of OMS721 rapidly approached a plateau, which correlated with maximal inhibition of lectin pathway activation, within six hours of administration and maintained that level of inhibition for two or more weeks. In addition, the observed bioavailability and pharmacokinetics 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.