Ardelyx presents XPHOZAH safety data at kidney foundation meeting

Ardelyx Inc. (NASDAQ: ARDX) presented analysis supporting the long-term safety of its drug XPHOZAH at the National Kidney Foundation's Spring Clinical Meetings in New Orleans. The data came from a post hoc analysis of the NORMALIZE and OPTIMIZE clinical trials.

XPHOZAH is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease on dialysis. The drug serves as add-on therapy for patients who have inadequate response to phosphate binders or cannot tolerate phosphate binder therapy.

The analysis examined data from an 18-month extension study and a 26-week study. Results showed that tenapanor treatment resulted in no clinically meaningful changes in measured serum electrolyte concentrations other than phosphate reduction. The analysis also found no significant changes in nutrition, body mass, or blood pressure.

"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, Chief Medical Officer of Ardelyx.

XPHOZAH works by blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. Diarrhea was the most common side effect in clinical trials, occurring in 43-53% of patients.

Ardelyx also sponsored a peer exchange session titled "Treating Hyperphosphatemia and Side Effect Management" during the conference.

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