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Omeros Corporation (OMER) Announces Positive OMS721 Data in Model of Age-Related Macular Degeneration



11/5/2013 9:04:41 AM

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SEATTLE, Nov. 5, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program, in a well-established animal model of neovascular age-related macular degeneration (AMD), which is characterized by abnormal growth of new blood vessels behind the retina of the eye and is a leading cause of vision loss in individuals over 60 years of age. Omeros is currently completing a Phase 1 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 1 clinical program evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered intravenously and subcutaneously in healthy subjects. A Phase 2 clinical trial in patients suffering from TMAs, including atypical hemolytic uremia syndrome, is planned to begin enrollment in early 2014.

"The data from this study directly evaluating the activity of OMS721, our lead MASP-2 inhibitor currently in a Phase 1 clinical program, further support its potential effects in the treatment of a wide range of complement-related diseases in humans," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We look forward to reporting the results of our Phase 1 clinical trial and the initiation of enrollment in our Phase 2 program."

About Omeros' MASP-2 Program

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, 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. MASP-2 appears to be unique to, and required for the function of, one of the principal complement activation pathways, known as the lectin pathway. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into the circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. Therefore, Omeros believes that it may be possible to deliver MASP-2 antibodies systemically and OMS721, its lead MASP-2 antibody, is designed to be self-administered by subcutaneous injection.

Omeros also believes that it has identified the proteins that activate the complement system's alternative pathway in humans, which is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the Company is advancing the development of antibodies that would block activation of the alternative pathway alone or in combination with the lectin pathway.

About Omeros Corporation

Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company's lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for 2014. Omeros' five other clinical programs are focused on schizophrenia, Huntington's disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. These statements include, but are not limited to, Omeros' expectations regarding the indications and diseases that may be treated by OMS721; the potential preventative and therapeutic effects of OMS721; enrollment in a Phase 2 clinical trial in early 2014; and the commercial launch of OMS302. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2013. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

SOURCE Omeros Corporation



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