Animal Model Positive for Omeros AMD Treatment

Omeros Corp. posted positive data for OMS721 in a well-established animal model of neovascular age-related macular degeneration (AMD). OMS721 is the company’s lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program. Omeros is currently completing a Phase I clinical trial of OMS721 in healthy subjects.

The study was conducted by Dr. Puran S. Bora and colleagues at the Jones Eye Institute, Pat and Willard Walker Eye Research Center of the University of Arkansas for Medical Sciences. In this animal model, new vessel growth in the eye is induced by laser treatment. Systemically administered OMS721 resulted in less than half of the blood vessel development compared to placebo treatment. The study included an antibody to vascular endothelial growth factor (VEGF) that also reduced blood vessel growth, and OMS721 outperformed the anti-VEGF treatment. Anti-VEGF treatment is the current mainstay of commercially available therapies for neovascular AMD.

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, and both human genetic and animal studies have linked the complement system to AMD development. 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. Omeros recently reported preclinical findings indicating that blockade of MASP-2 by OMS721 may also have a preventive or therapeutic effect in the treatment of thrombotic microangiopathy (TMA), a disorder that occurs in the microcirculation (e.g., venules and capillaries) of the body’s organs, most commonly the kidney and brain.

In July of this year, Omeros began enrollment in its Phase I study evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered intravenously and subcutaneously in healthy subjects. A Phase II trial in patients suffering from TMAs, including atypical hemolytic uremia syndrome, is planned to begin enrollment in early 2014.