Ardelyx has announced positive topline data from its Ibsrela (tenapanor) study, evaluating the investigational drug for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
The study, dubbed the PHREEDOM trial, met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change compared to the placebo arm.
The company announced that during the 26-week treatment period, 77% of tenapanor-treated patients in the intent-to-treat population had a decrease in serum phosphorus, with a mean reduction from baseline of 2.0 mg/dL.
If approved, the drug - which is an investigational, first-in-class, phosphate absorption inhibitor - will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.
The treatment is “poised to change the way we manage hyperphosphatemia in patients on dialysis” explained Myles Wolf, professor of medicine and chief of Duke Nephrology.