Relypsa, Inc., 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.

"We are pleased to advance our lead compound RLY5016 into Phase 2b clinical testing, following very encouraging tolerability and efficacy results observed in Phase 1 and Phase 2a clinical trials," said Detlef Albrecht, M.D., Chief Medical Officer and Senior Vice President, Drug Development of Relypsa. "RLY5016 holds great promise in preventing and treating hyperkalemia, and thereby enhancing the use of life-saving drugs for heart failure patients. 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."

Relypsa's Chief Operating Officer, Gerrit Klaerner, Ph.D. commented, "We are proud to achieve this milestone in a capital- and time-efficient manner. Since Relypsa's inception less than two years ago, we have made remarkable progress by advancing a preclinical asset through human proof-of-concept. We anticipate interim results from the Phase 2b trial will help us to position RLY5016 as an essential tool for cardiologists and nephrologists to optimize the use of cardiovascular agents with proven outcomes. The practice of deploying therapies that address toxicities and side effects of life-saving treatments is well established in oncology, but this will be a first in the cardiovascular field. Our goal is to establish Relypsa as one of the leading companies focused on patients with chronic cardio-renal diseases."

Source
Relypsa, Inc.