Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage company focused on enhancing the treatment of patients with gastrointestinal and cardiorenal diseases, today announced the initiation of a Phase 3 clinical trial and an onset-of-action clinical trial evaluating RDX7675 in patients with hyperkalemia, a potentially life-threatening condition common in patients with cardiorenal disease.
"The Phase 3 study for hyperkalemia marks the start of the fifth Phase 3 clinical trial from our pipeline of internally developed, gut-restricted treatments in development," said Mike Raab, chief executive officer of Ardelyx. "Hyperkalemia is a difficult to treat and potentially devastating condition in patients with chronic kidney disease and/or heart failure. The initiations of the Phase 3 and onset-of-action trials with RDX7675 are important steps forward for our cardiorenal portfolio, as we look to bring better treatments to underserved patients who aren't satisfied with their current care. We look forward to further evaluating its treatment potential and reporting data from the onset-of-action study in the first half of the year."
The Phase 3 clinical trial is a randomized, single-blind, three-part study that will evaluate the efficacy and safety of RDX7675 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.