Relypsa Begins Phase 2b Clinical Trial For RLY5016

Relypsa has initiated patient enrollment in the PEARL-HF study, a phase 2b clinical trial of the company’s lead compound, RLY5016. Its a novel potassium binder designed for chronic use, and is being evaluated in the prevention and treatment of hyperkalemia.

Reportedly, PEARL-HF phase 2b clinical trial is a multi-center, randomised, 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.

The result of the studies suggested that RLY5016 was well-tolerated. 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.

Detlef Albrecht, chief medical officer and senior vice president of drug development at Relypsa, said: “We are pleased to advance our lead compound RLY5016 into phase 2b clinical testing, following encouraging tolerability and efficacy results observed in phase 1 and phase 2a clinical trials. To date, we have been pleased by the interest received from clinical investigators and the positive enrollment trends observed in the first portion of the trial. We look forward to reporting interim results from the PEARL-HF phase 2b clinical trial in the first quarter of 2010.”