|Keryx Announces Zerenex LT Phase 3 Results; Esperion Announces Initiation of a Phase 2 Clinical Study of ETC-1002|
|By Mary Davila|
|Thursday, 24 July 2014 18:24|
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced the publication of results from the long-term, randomized, active control Phase 3 study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis. The PERFECTED study (PhosphatE binding and iRon delivery with FErric CiTrate in EsrD) was published online today in the Journal of the American Society of Nephrology (JASN).
This Phase 3 study was a multicenter, randomized, open-label trial in 441 ESRD patients on hemodialysis or peritoneal dialysis designed to determine the safety and efficacy of Zerenex as a treatment to reduce serum phosphorus as well as raise iron stores and reduce intravenous (IV) iron and erythropoietin-stimulating agents (ESA) usage.
Zerenex met the study's primary end-point demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Placebo Control Period. Using a sequential gatekeeping strategy for the key pre-defined secondary end-points, Zerenex also demonstrated statistically significant increases in serum ferritin and transferrin saturation (TSAT), and significant reductions in the use of IV iron and ESAs, versus an active control of Renvela® (sevelamer carbonate) and/or Phoslo® (calcium acetate) over the 52-week Active Control Period of the study. In addition, mean hemoglobin levels were higher in subjects treated with Zerenex as compared to subjects treated with active control.
"Zerenex effectively reduces serum phosphorus levels within the KDOQI range (3.5 mg/dL to 5.5 mg/dL) while having the additional patient benefits of increasing iron stores and decreasing the need for IV iron and ESAs, while maintaining hemoglobin levels," said Julia Lewis, MD, lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. "If approved, the combined benefits of Zerenex would be of value for patients, health care professionals and the healthcare system."
The Company's New Drug Application (NDA) for Zerenex is currently under review by the U.S. Food and Drug Administration (FDA).
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very pleased with the publication of the Phase 3 PERFECTED study results in a premier peer-reviewed nephrology journal and are encouraged by Zerenex's potential differentiated product profile." Mr. Bentsur added, "We thank the investigators and patients who participated in this study and look forward to potentially bringing Zerenex to market in the U.S."
Phosphorus Control is Necessary for Most ESRD Patients on Dialysis -- In the United States, according to data from the U.S. Renal Data System, there are currently approximately 600,000 ESRD patients, with the number of ESRD patients projected to rise in the future. The majority of ESRD patients in the United States, more than 400,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are associated with secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and an increase in adverse cardiovascular events. Hyperphosphatemia is ubiquitous in ESRD, with the majority of the patients requiring chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels.
Zerenex Administration Over 52 Weeks Increased Iron Stores -- In addition, approximately seventy percent of dialysis patients are truly or functionally iron depleted, suffer from anemia and require treatment with IV iron and/or ESA injections. The newly published clinical trial results show that, in addition to its efficacy as a phosphate binder, Zerenex also significantly raises iron stores as measured by serum ferritin and TSAT.
The results showed Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in serum ferritin (+306 ng/mL vs. +19 ng/mL) and TSAT (+8% vs -1.2%) from baseline (day 0) to week 52. In the PERFECTED study, subjects randomized to receive Zerenex required significantly lower dosages of IV iron and ESA; and hemoglobin levels were higher in Zerenex treated patients than in those receiving active control.
The investigators cited an analysis of the trial results that indicated that the projected reduction in the need for IV iron and ESA use would result in significant pharmaco-economic benefits. In addition, the investigators wrote, "one would postulate that decreased IV iron and ESA usage could result in decreased nursing time to administer IV medications which could be redirected to other aspects of patient care and decreased risk of infections due to fewer IV injections." In the PERFECTED study, fewer serious adverse events (SAEs) due to infection were seen in the subjects randomized to Zerenex compared to active control.
The authors noted that, if approved, Zerenex would be the only phosphate binder that also increases iron stores and decreases IV iron and ESA use.
Esperion Therapeutics, Inc. (Nasdaq: ESPR), a clinical-stage biopharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers, today announced dosing of the first patient in its Phase 2 clinical study of ETC-1002 in patients with hypercholesterolemia and hypertension, ETC-1002-014. The company expects to announce top-line results from the study in the second quarter of 2015.
“Many patients with high LDL-cholesterol levels also have hypertension. This clinical study will help to further elucidate the LDL-cholesterol lowering efficacy, safety and tolerability profile of ETC-1002 in patients with both hypercholesterolemia and hypertension,” said Tim M. Mayleben, president and chief executive officer of Esperion.
The randomized, double-blind, parallel group, multicenter ETC-1002-014 study is evaluating parallel doses of ETC-1002 in approximately 144 patients. The primary objective of the study is to assess the LDL-cholesterol lowering efficacy of ETC-1002 monotherapy versus placebo in patients with both hypercholesterolemia and hypertension who are treated for six weeks. Secondary objectives include assessing the effect of ETC-1002 on blood pressure, other lipid and cardiometabolic biomarkers and characterizing the tolerability and safety of ETC-1002.
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Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced the publication of results from the long-term, randomized, active control Phase 3 study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis.
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