Ardelyx announces publication of 52-week phase III PHREEDOM trial

Arnold Silva, M.D., Ph.D., director of Clinical Research at Boise Kidney and Hypertension Institute, added, "As an investigator in this clinical trial and an author on this publication, I have had the opportunity to see both first-hand and in aggregate the impact of tenapanor on the control of serum phosphorus. I believe this novel mechanism therapy will play a key role in advancing the management of hyperphosphatemia in our patients with CKD on dialysis, an area where treatment options have been limited, and a significant proportion of patients have phosphorus levels above target ranges despite active treatment with currently available therapies. Additionally, a one pill twice daily therapy that blocks phosphorus absorption, whether used alone or in combination with phosphate binders, has the potential to reduce treatment burden, which will be a very meaningful benefit to patients."

About the PHREEDOM Study : PHREEDOM is a 52-week monotherapy trial that demonstrated a clinically meaningful decrease in mean serum phosphorus in tenapanor-treated patients from 7.7 mg/dL at baseline to 5.1 mg/dL at the end of the 26-week treatment period in the efficacy analysis set (n=131), and a clinically meaningful decrease in mean serum phosphorus in the tenapanor-treated patients from 7.4 mg/dL at baseline to 5.9 mg/dL at week 26 in the intent-to treat analysis set (n=248). Additionally, in the efficacy analysis set (n=131), the difference in estimated mean change in serum phosphorus level between tenapanor and placebo from the beginning to the end of the randomized withdrawal period was -1.4 mg/dl (P<0.0001). furthermore, there were median relative reductions from baseline of 23% for ifgf23 and 14% for cfgf23 at the end of the randomized 26-week treatment period for participants randomized to tenapanor. diarrhea was the only drug related ae reported for more than 5% of patients and resulted in drug discontinuation in 16% of patients.></0.0001).>