Publication highlights clinically meaningful reduction in mean serum phosphorus from 7.7 mg/dL to 5.1 mg/dL at end of 26-week treatment period in the efficacy analysis set.

FREMONT, Calif. and WALTHAM, Mass., Sept. 3, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced the publication of the company's long term 52-week Phase 3 PHREEDOM trial in the American Society of Nephrology journal, Kidney360.

"The PHREEDOM trial, a 52-week randomized Phase 3 trial that evaluated tenapanor monotherapy, was the third of three Phase 3 trials we conducted in our comprehensive evaluation of tenapanor for the control of serum phosphorus in patients with chronic kidney disease on dialysis," said Mike Raab, president and chief executive officer of Ardelyx. "The PHREEDOM data demonstrate the ability of tenapanor to provide significant phosphorus reduction with long-term safety comparable to active control. This study, together with data from our AMPLIFY trial which evaluated tenapanor in combination with binders in patients who require more aggressive phosphate management, supports the central role tenapanor, with its novel blocking mechanism, can play across a broad range of patients and treatment regimens for the management of hyperphosphatemia in patients with chronic kidney disease on dialysis."

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