SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced further expansion of its OMS721 compassionate use program to Finland. OMS721 is Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome (aHUS).
Based on review of OMS721 data, Finnish physicians requested access to OMS721 under a Special License, granted by the Finnish regulatory authorities, to treat a patient with aHUS. The patient was previously treated with Soliris® (eculizumab) but was determined to not have an adequate response, continuing to display signs of active aHUS. The patient is expected to begin treatment with OMS721 next month.
In other recent compassionate use, OMS721 was provided to a young patient on long-term dialysis. Because of her active aHUS, she was not healthy enough for kidney transplantation. Following treatment with OMS721, her clinical status stabilized and the investigator has determined that her aHUS is no longer an impediment to kidney transplantation. Omeros is working with her physicians to assure availability of OMS721 throughout her transplantation and postoperatively.
“Omeros is committed to continue working with physicians to enable patients with aHUS and other TMAs to receive OMS721,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We are helping patients who, for whatever reason, have not adequately responded to or cannot access Soliris and need a different option to treat these devastating diseases. It is gratifying to see that, following OMS721 treatment, the dialysis-dependent patient is considered eligible for kidney transplantation, and we look forward to helping the Finnish patient for whom Soliris was ineffective. As physician requests increase, we continue to expand our compassionate use program, making OMS721 available to patients who need it.”
About Omeros’ MASP 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 is associated with a wide range of autoimmune disorders. 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. Omeros has received both orphan drug status and fast track designation from the U.S. FDA for its lead human MASP-2 antibody OMS721. Omeros is advancing to a Phase 3 clinical program evaluating OMS721 in the treatment of atypical hemolytic uremic syndrome and is continuing its Phase 2 program targeting thrombotic thrombocytopenic purpura and stem cell transplant-related thrombotic microangiopathies. In addition, an OMS721 Phase 2 program has been initiated in complement-related renal diseases. An investigator-requested compassionate use program for OMS721 is also underway. OMS721 has demonstrated no safety concerns in human trials or chronic toxicity studies. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a 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’s OMS906 program is advancing the development of antibodies targeting MASP-3 that block activation of the alternative pathway.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both 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 (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, European Commission has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; complement-mediated glomerulopathies; Huntington’s disease and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros 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.
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 product commercialization including with respect to Omidria® and OMS103, Omeros’ ability to partner and commercialize Omidria in Europe, Omeros’ unproven preclinical and clinical development activities, regulatory oversight, 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 November 9, 2015. 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.