Ardelyx Reports Positive Results From End-of-Phase 2 Meeting With FDA

(RTTNews) - Ardelyx Inc. (ARDX) announced that, based on the positive outcome of a recent End-of-Phase 2 or EoP2 meeting held with the U.S. Food and Drug Administration, its ongoing Phase 2b clinical trial evaluating tenapanor for the treatment of hyperphosphatemia for end-stage renal disease or ESRD patients on dialysis, may serve as the first of two registration trials to support the filing of a new drug application or NDA.

Additionally, the company announced the results of a pharmacodynamic or PD study evaluating once daily (QD) dosing of its product candidate, RDX227675, for the treatment of hyperkalemia. With these positive results, Ardelyx is accelerating its plans to commence a time to onset clinical trial in patients with hyperkalemia.

Ardelyx recently met with the FDA for an EoP2 meeting regarding tenapanor for the treatment of hyperphosphatemia for ESRD patients on dialysis. The FDA guided Ardelyx to use the results of the placebo-controlled randomized withdrawal portion of the trial as the primary endpoint for its ongoing clinical trial, rather than as a secondary endpoint, in order for the trial to serve as one of two well-controlled studies to support the registration of tenapanor for the treatment of hyperphosphatemia for ESRD patients on dialysis. The overall study design will not be changed, but the Company is increasing the number of patients to be enrolled in the trial from 150 to 200 to further strengthen the trial and maintain a power of 90%.

The FDA has accepted the new statistical analysis plan submitted to reflect certian changes. As a result of the increase in enrollment, Ardelyx now expects results from the ongoing trial to be reported in the first quarter of 2017, as compared to prior guidance of the second half of 2016.