Keryx Biopharmaceuticals Inc. Announced Positive Results in Phase II for its Kidney Disease Drug – Zerenex. (KERX)

June 9, 2009 · Filed Under General 

Shares of Keryx Biopharmaceuticals Inc. (Nasdaq: KERX) rose on June 8th  after the company reported positive Phase 2 results for its kidney disease drug, Zerenex (ferric citrate),  a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on tri-weekly hemodialysis.

Keryx Biopharmaceuticals Inc. ended the day up 0.27 (25.00%) with a closing trade price of 1.35.

The study was a multicenter, open-label clinical trial, which enrolled 55 patients. The primary objective of this study was to assess the tolerability and safety of Zerenex (ferric citrate) with doses ranging from approximately 1 gram per day to 12 grams per day. The FDA indicated that the results of the Phase 2 study were adequate to support entry into a Phase 3 program. Keryx is in the process of finalizing the Phase 3 program in consultation with the FDA.

Patients were treated with Zerenex (ferric citrate) for four weeks and were titrated weekly to achieve and maintain normal serum phosphorus level, between 3.5 to 5.5 mg/dL, the therapeutic goal.

Dr. Julia Lewis, Professor of Medicine at Vanderbilt University, the Principal Investigator in the study, commented, “This study, as well as earlier studies, suggest that Zerenex is an effective, tolerated phosphate binder that will potentially make a significant clinical addition to treating the important universally present problem of hyperphosphatemia in patients with end-stage renal disease.”

Sales of phosphate binders to treat hyperphosphatemia in ESRD patients in the U.S. were approximately $600 million in 2007, and have grown in excess of 20% per annum over the last five years.

Joshua Sherman

Tags:

Comments

Comments are closed.

    Subscribe to BioHealth Investor BioHealth Investor RSS Feed