Keryx Biopharmaceuticals (KERX) Announces Positive Data From Zerenex Short-Term Phase 3 Study
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Keryx Biopharmaceuticals (Nasdaq: KERX) announced the final dataset from the Phase 3 short-term clinical trial of Zerenex (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis.
The Zerenex data was presented earlier today at the National Kidney Foundation Spring Clinical Meetings being held in Las Vegas, Nevada, in an oral presentation by David S. Goldfarb, M.D., Clinical Chief of Nephrology, NYU Langone Medical Center, Professor of Medicine & Physiology, NYU School of Medicine. On November 30, 2010, the Company issued a press release announcing positive top-line results from this Phase 3 short-term study.
The primary endpoint of the study was to determine whether there was a dose response in the change in serum phosphorus from Baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.
The study met the primary endpoint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).
The Zerenex data was presented earlier today at the National Kidney Foundation Spring Clinical Meetings being held in Las Vegas, Nevada, in an oral presentation by David S. Goldfarb, M.D., Clinical Chief of Nephrology, NYU Langone Medical Center, Professor of Medicine & Physiology, NYU School of Medicine. On November 30, 2010, the Company issued a press release announcing positive top-line results from this Phase 3 short-term study.
The primary endpoint of the study was to determine whether there was a dose response in the change in serum phosphorus from Baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.
The study met the primary endpoint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).
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