Relypsa, Inc., today announced the initiation of patient enrollment in the PEARL-HF study, a Phase 2b clinical trial of the company’s lead compound, RLY5016. A novel potassium binder designed for chronic use, RLY5016 is being evaluated in the prevention and treatment of hyperkalemia, for which there are no current satisfactory treatments.
Hyperkalemia is a condition characterized by elevated serum potassium levels, which can lead to cardiac arrhythmia and sudden death. Heart failure patients are at particular risk for developing hyperkalemia, especially those patients with underlying chronic kidney disease treated with Renin-Angiotensin-Aldosterone-System (RAAS) inhibitors. RAAS inhibition in such patients provides a life-saving therapy, but has the undesirable side effect of increasing serum potassium.
The PEARL-HF Phase 2b clinical trial is a multi-center, randomized, placebo-controlled study designed to assess the efficacy, safety and tolerability of RLY5016 for the prevention of hyperkalemia in heart failure patients. The study is being conducted at clinical sites worldwide and patient enrollment is underway.
The Phase 2b clinical trial follows the successful completion of three clinical trials of RLY5016, including two Phase 1 trials and a Phase 2a trial. RLY5016 was well-tolerated in these studies. In healthy volunteers, RLY5016 demonstrated dose-related pharmacological effects. In a Phase 2a clinical trial of hemodialysis patients with hyperkalemia, RLY5016 lowered serum potassium, achieving proof-of-concept.