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Ardelyx Announces Positive Topline Results from Pivotal Phase 3 PHREEDOM Study Evaluating Tenapanor in CKD Patients on Dialysis
FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class
About this update from Ardelyx, Inc.
[{"type":"text","content":"FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. 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. During the 26-week treatment period, 77% of tenapanor-treated patients in the intent-to-treat population (n=408) had a decrease in serum phosphorus, with a mean reduction from baseline of 2.0 mg/dL. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis. If approved, tenapanor will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.\n\n \n\"If approved, tenapanor is poised to change the way we manage hyperphosphatemia in patients on dialysis,\" said Myles Wolf, M.D., MMSc, Charles Johnson, M.D. professor of medicine and chief of Duke Nephrology. \"Tenapanor would be a first-in-class therapy that targets the primary pathway of phosphate absorption to significantly lower serum phosphate while requiring patients to take just one small pill twice per day. This would make tenapanor an important innovation and potentially an ideal first-line therapy for patients receiving dialysis for whom new effective treatments are desperately needed.\" \n\"These results are very exciting and represent a capstone to our tenapanor clinical development program, which is focused on the development of a new and important therapy for patients with hyperphosphatemia,\" said Mike Raab, president and chief executive officer of Ardelyx. \"Based on the PHREEDOM data that demonstrate tenapanor as an effective monotherapy, and the previously released AM...