Positive new data on Ardelyx' tenapanor for the treatment of hyperphosphatemia

California, USA-based cardiorenal specialist Ardelyx (Nasdaq: ARDX) yesterday reported positive top-line results from PHREEDOM, a long-term Phase III study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Initial market reaction was negative, with the stock falling as much as 6.8% in early trading, but Ardelyx’ shares closed on a high on Tuesday, up 11.29% at $8.05.

In the study, patients randomized to the tenapanor arm were treated in a 26-week open-label treatment period and were then re-randomized to a 12-week double-blind, placebo-controlled randomized withdrawal period. The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo.