EmailStory Stocks®
Archive
Last Update: 28-Jan-13 07:39 ET
Keryx BioPharma shares soar 39% as Zerenex meets primary endpoint
Keryx Biopharma (KERX $4.76 +1.33) announced successful top-line results from the long-term Phase 3 study of Zerenex, the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Efficacy Assessment Period of the study. In addition, Zerenex met the key secondary endpoints of increasing ferritin and transferrin saturation and reducing the use of intravenous iron and erythropoiesis-stimulating agents versus the active control over the 52-week Safety Assessment Period of the study. This long-term study was the final component of the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment with the FDA. In April 2011, the Company reported the positive final dataset from the short-term study component of this Phase 3 registration program. The Company expects to submit a New Drug Application with the FDA and a Marketing Authorization Applicationwith the European Medicines Agency for Zerenex in the second quarter of 2013. Endpoint Details The primary efficacy endpoint of this trial was the mean change in serum phosphorus from baseline (Week 52) to end of the four-week Efficacy Assessment Period (Week 56) versus placebo in the Intent-to-Treat (ITT) group. The ITT group included 183 subjects, representing all subjects who took at least one dose of Zerenex or placebo in the Efficacy Assessment Period and provided at least one post-baseline efficacy assessment. Zerenex met the primary efficacy endpoint with a highly statistically significant result. During the 52-week Safety Assessment Period, Zerenex maintained serum phosphorus in the normal range, with highly statistically significant changes in mean serum phosphorus concentration at Weeks 12, 24, 36, 48, and 52 as compared to baseline (Day 0). Zerenex successfully achieved the non-inferiority endpoint versus Renve. Safety Profile The overall serious adverse event rates in the study were 34% Zerenex vs. 43% Active Control. Importantly, there were no clinically meaningful or statistically significant differences between Zerenex and the active control group in serum calcium levels and liver enzymes, as measured by alanine transaminase and aspartate transaminase.
