KERX +.27 to 13.35 after announcing the start of a phase 3 study for expanded use of Ferric Citrate -
NEW YORK, Sept. 29, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today the initiation of its pivotal Phase 3 study of Ferric Citrate for the treatment of iron deficiency anemia in patients with non-dialysis dependent (Stage 3-5) chronic kidney disease ("NDD-CKD"). On September 5, 2014, the U. S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex™) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
"We are thrilled to be initiating this pivotal study to evaluate Ferric Citrate as a treatment for iron deficiency anemia in patients with stages 3 - 5 of CKD," commented Ron Bentsur, Keryx's Chief Executive Officer. "We are encouraged by the positive results observed in our Phase 2 study in this patient population and we believe that the study commencing today, if successful, will support indication expansion for Ferric Citrate."
The Phase 3 study initiated today, entitled "A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia in Adult Subjects with Non-Dialysis Dependent Chronic Kidney Disease," is a multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period in which all subjects receive Ferric Citrate ("Extension Period"), for a total of 24 weeks. Approximately 230 subjects, who have previously had an inadequate response to oral iron supplements, will be randomized into the Randomized Period in a 1:1 ratio to receive either Ferric Citrate or matching placebo. Intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) use is prohibited during and leading up to the study. There are currently no oral iron formulations that are FDA approved for the treatment of iron deficiency anemia in CKD patients.
This study's primary endpoint is the between group comparison of the proportion of patients achieving a 1 g/dL or greater increase in hemoglobin at any point during the 16-week Randomized Period. In the 12-week Phase 2 study in NDD-CKD previously conducted by Keryx, a post-hoc analysis of this endpoint demonstrated that the proportion of patients achieving a 1g/dL or greater increase in hemoglobin at any time point during the study was 40% in the Ferric Citrate arm vs. 15% in the placebo arm (p-value <0.001). Secondary endpoints in the Phase 3 study include change from baseline to end of Randomized Period for hemoglobin, ferritin, TSAT and serum phosphorous.
The study's Co-Chairmen are Geoffrey Block, MD, Director of Clinical Research at Denver Nephrology; Glenn Chertow, MD, Professor of Medicine and Chief, Division of Nephrology at Stanford University School of Medicine; and Steven Fishbane, MD, Division Chief, Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center. The study will be conducted at approximately 40 sites in the U.S.
Dr. Block, commented, "We believe that Ferric Citrate could represent an advancement in the treatment of iron-deficiency anemia for this underserved patient population. The ability to potentially treat CKD patients with iron deficiency anemia with an oral agent could be compelling for physicians and patients."
Dr. Chertow, added, "Current treatment strategies for iron deficiency anemia in CKD are clearly not optimal. There are safety concerns regarding the use of intravenous iron. Moreover, IV iron administration always requires supervision in a healthcare setting, and frequently obligates cannulation of the forearm veins we aim to preserve for hemodialysis vascular access. Commercially available oral iron preparations are generally ineffective due to limited absorption and are poorly tolerated. As such, the population of patients with CKD and iron deficiency anemia remains underserved."
Dr. Fishbane, stated, "As CKD progresses, the prevalence of iron deficiency anemia increases. It is estimated that there are well over 1.5 million CKD stages 3-5 patients with iron deficiency anemia. If approved in this indication, Ferric Citrate could represent a viable treatment option for these patients."
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Ferric Citrate from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
About Non-Dialysis Dependent Chronic Kidney Disease and Iron Deficiency Anemia
It is estimated that approximately 10% to 15% of the U.S. adult population is affected by chronic kidney disease (CKD), a condition generally characterized by greater than 50% reduction of normal kidney function. Iron deficiency anemia, which develops early in the course of CKD and worsens with disease progression, is extremely prevalent in the NDD-CKD population and is associated with fatigue, lethargy, decreased quality of life and is also believed to be associated with cardiovascular complications, hospitalizations, and increased mortality. Based on data contained in a 2009 publication in the Journal of the American Society of Nephrology, it is estimated that over 1.5 million adults with NDD-CKD in the U.S. alone are also afflicted with iron deficiency anemia. To combat this anemia, iron replacement therapy is essential to increase iron stores, such as ferritin and TSAT levels, and raise hemoglobin levels.
