Phase III trial of RLY 5016 for Hyperkalemia meets endpoints-Relypsa

Relypsa Inc. has announced new data from its pivotal Phase III clinical trial of RLY 5016 (patiromer) demonstrating its ability to correct and prevent recurrence of Hyperkalemia in Heart Failure and Non-Heart Failure Patients. The primary endpoint of Part A was the change in serum potassium from Part A baseline to Part A week 4. Part B, the placebo controlled randomized withdrawal phase of the trial, was designed to provide additional evidence of the efficacy of patiromer in treating hyperkalemia and to assess the need for chronic dosing.

All Part A and Part B efficacy endpoints for patients with and without HF were met. For the Part A primary endpoint, a statistically significant reduction in serum potassium of 1.06 mEq/L was demonstrated in patients with HF which was similar to the reduction demonstrated for those without HF. For the Part B primary endpoint, the difference between the placebo and the patiromer groups in the median change from Part B baseline in serum potassium in patients with HF was 0.64 mEq/L which was also similar to that demonstrated in patients without HF.

In addition, fewer heart failure patients in the patiromer group experienced recurrent hyperkalemia than the placebo group (8 percent compared to 52 percent) with a similar trend in non-heart failure patients (23 percent compared to 66 percent). Consequently, more patiromer-treated patients remained on guideline-recommended RAASi therapy compared to placebo. Patiromer was well tolerated in both HF and non-HF patients with a low risk of hypokalemia.Data were presented at the 18th Annual Scientific Meeting for the Heart Failure Society of America.