Omeros Announces Positive Data for MASP-2 Inhibitor in Experimental Model of Stroke

SEATTLE, Nov. 6, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced positive data using a derivative of OMS721 in a well-established animal model of stroke. OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). MASP-2 is critical to the function of the lectin pathway, one of the principal components of the complement system, a key part of the immune response. Omeros controls the worldwide rights to MASP-2 inhibition and to all therapeutics targeting MASP-2.

The study evaluated the effect of MASP-2 blockade on neurological deficits and the size of brain infarcts 48 hours after induction of an ischemic stroke. Compared to control antibody-treated mice, mice treated with MASP-2 antibody demonstrated significantly reduced neurological deficits 48 hours after an ischemic stroke. In addition, the infarcted area of the brain was significantly smaller in MASP-2 antibody-treated mice. A similar degree of protection was also observed in gene-targeted MASP-2-deficient mice, which showed significantly lesser neurological deficits and infarct sizes compared to wild-type control mice.

The study was conducted by the team of Dr. Maria-Grazia de Simoni, director of the Laboratory of Inflammation and Nervous System Diseases at the Mario Negri Research Institute in Milan, in collaboration with Dr. Wilhelm Schwaeble, professor of immunology at the University of Leicester and Royal Society-Wolfson Research Merit Award Holder. "The data from this study clearly identify the lectin pathway as a central contributor to the damage and disability resulting from the ischemic injury of stroke," stated Dr. de Simoni. "Our findings are consistent with human clinical data supporting the importance of the lectin pathway in stroke and underscore the attractiveness of MASP-2 as a potential target for the treatment of stroke patients."

Every year, more than 800,000 people in the U.S. suffer a stroke, almost 90 percent of which are ischemic, and approximately one out of six are fatal. A leading cause of serious long-term disability, the cost of stroke in the U.S. is estimated at $37 billion annually [http://www.cdc.gov/stroke/facts.htm].

"These results are exciting and expand our understanding of the lectin pathway's central role in ischemia-reperfusion injury across multiple organs, including the brain, heart and kidney," said Gregory A. Demopulos, chairman and chief executive officer of Omeros Corporation. "The importance of the lectin pathway and of MASP-2, the pathway's critical effector enzyme, in the pathogenesis of a wide range of diseases and disorders continues to grow within the complement research community, and Omeros plans to explore a wide range of clinical indications for OMS721 and our MASP programs."

OMS721 is currently being evaluated in a Phase 2 clinical trial in patients with complement-mediated thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenic purpura (TTP), and stem cell transplant-related TMAs. Thrombotic microangiopathies are a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. Omeros expects to be able to release data later this month on the effect of OMS721 on thrombus formation in a human ex vivo pathophysiologic system of aHUS using serum from aHUS patients both in the acute phase and in remission. 

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 biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery^® platform, the Company's first drug product, Omidria^™ (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. Omeros is completing preparations for a planned U.S. product launch no later than early 2015. Omidria is currently under review for marketing approval by the European Medicines Agency. Omeros also has six clinical-stage development programs focused on complement-related thrombotic microangiopathies, Huntington's disease, schizophrenia, and cognitive impairment; on addictive and compulsive disorders; and on 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. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. 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, risks associated with effectiveness of Omidria^™ sales and marketing efforts, Omidria market acceptance, product pricing and reimbursement, Omeros' ability to obtain regulatory approval for its Marketing Authorization Application in the EU for the commercialization of Omidria, Omeros' unproven preclinical and clinical development activities, regulatory oversight, product commercialization, intellectual property claims, competitive developments, litigation, and 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 11, 2014. 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, even if new information becomes available in the future.

SOURCE Omeros Corporation