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Omeros Announces Toxicology Data That Support Advancing MASP-2 Inhibitor Into Clinical Trials

"As we wrap up our CTA-enabling studies, OMS721 continues to impress with its potential competitive advantages, including subcutaneous administration, convenient dosing, and maintenance of the acquired immune response to infection," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMS721 holds significant promise to treat a wide range of immune-related disorders, and today's data further underscore the commercial opportunities for OMS721.  We plan to focus initially on aHUS, a rare and life-threatening indication seen most commonly in children. Submission of our CTA is expected next quarter, and we look forward to evaluating the drug product soon in clinical trials."

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.

Omeros also believes that it has identified the proteins that activate the complement system's alternative pathway, 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.

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