Ardelyx Inc., initiates Phase III trial of RDX 7675 to treat hyperkalemia.

Ardelyx, Inc. a clinical-stage company focused on enhancing the treatment of patients with gastrointestinal and cardiorenal diseases, announced the initiation of a Phase III clinical trial and an onset-of-action clinical trial evaluating RDX 7675 (formerly RDX 227675) in patients with hyperkalemia, a potentially life-threatening condition common in patients with cardiorenal disease. The Phase III clinical trial is a randomized, single-blind, three-part study that will evaluate the efficacy and safety of RDX 7675 in approximately 300 adult patients with hyperkalemia and includes a long-term, open-label safety extension. The onset-of-action trial is a single-blind, placebo controlled study evaluating the onset-of-action, safety and efficacy of RDX7675 in 60 patients with hyperkalemia.

Comment: As a result of hyperkalemia, many physicians opt to lower the dose of, or discontinue, potentially life-saving drugs such as ACE inhibitors that, as a side-effect, tend to increase serum potassium, rather than risk the potential dangers of this side effect in their CKD or heart failure patients. In addition, the RDX 7675 formulation does not contain sodium or sorbitol, has significantly improved palatability, and with a convenient once or twice daily dosing, has the potential to provide significant benefits to patients with hyperkalemia.