Ardelyx Presents Data Analysis Evaluating Long-Term Impact Of XPHOZAH On Serum Electrolytes And Selected Nutrition Biomarkers At The National Kidney Foundation Meetings

XPHOZAH is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.

"We are pleased to present a post hoc analysis of the NORMALIZE and OPTIMIZE open-label clinical trials at the NKF's Spring Clinical Meetings, providing further insight into the long-term safety of an XPHOZAH-based regimen in patients with hyperphosphatemia on maintenance dialysis who were not controlled on binder therapy," said Rajani Dinavahi, MD, Chief Medical Officer of Ardelyx. "Analyses such as these are important not only for understanding treatment outcomes, but also for supporting informed decision-making that can help optimize care and outcomes for these patients."

Previous analysis found that tenapanor inhibition of the sodium hydrogen exchanger (NEH3) did not affect serum electrolyte concentrations other than phosphate. The poster, titled "Tenapanor Decreases Serum Phosphate Without Altering Other Serum Electrolytes in Patients with Chronic Kidney Disease with Hyperphosphatemia on Dialysis," further supports that analysis over an extended period of time. Using data from two open-label trials, an 18-month extension study (NORMALIZE) and a 26-week study (OPTIMIZE), the analysis showed that tenapanor treatment resulted in no clinically meaningful changes in measured serum electrolyte concentrations, other than phosphate reduction, and no significant changes in nutrition, body mass, or blood pressure.

These findings support effectiveness of tenapanor for management of serum phosphate in patients with chronic kidney disease and hyperphosphatemia on dialysis, while also reinforcing reported safety data.