|Omeros Announces Positive OMS721 Data; Keryx Announces Zerenex(TM) Meets All Primary and Key Secondary Endpoints in Phase 2|
|By Staff and Wire Reports|
|Tuesday, 05 November 2013 20:26|
Omeros Corporation (NASDAQ: OMER) 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."
Keryx Biopharmaceuticals (Nasdaq: KERX) announced successful top-line results from its Phase 2 study of Zerenex™ (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia. In this study, Zerenex met both co-primary endpoints, described below, demonstrating highly statistically significant changes in serum phosphorus and transferrin saturation (TSAT) versus placebo over the 12-week treatment period. In addition, Zerenex met the key secondary endpoints of increasing ferritin and hemoglobin, and decreasing fibroblast growth factor-23 (FGF-23) versus placebo. The Company plans to meet with the Food and Drug Administration (FDA) to discuss these data with the goal of defining a path forward towards obtaining a labeled indication for the treatment of iron deficiency anemia in NDD-CKD patients.
The Co-Chairmen of the study were Geoffrey A. Block, MD, Director of Clinical Research at Denver Nephrology; Glenn Chertow, MD, Chief, Division of Nephrology and Professor of Medicine at Stanford University School of Medicine; and Steven Fishbane, MD, Chief, Division of Nephrology, Vice President of North Shore-LIJ Health System for Network Dialysis Services and Director of Clinical Research at North Shore-LIJ Department of Medicine.
Study Design: This Phase 2 study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with stage 3 to 5 NDD-CKD, with elevated serum phosphorus ≥4.0 mg/dL and iron deficiency anemia. The study consisted of a 2-week washout period (for subjects on a phosphate binder at screening) followed by a 12-week treatment period in which subjects were randomized 1:1 to receive either Zerenex or placebo. One hundred forty-nine (149) subjects were randomized into the study from 20 sites in the United States.
The use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) were not permitted within 8 weeks and 4 weeks prior to the study, respectively, and not permitted during the course of the study. Oral iron therapy was also not permitted during the course of the study.
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