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Ardelyx, Inc., a clinical-stage company, 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.
RDX7675 is an oral, non-absorbed potassium-binding polymer that has demonstrated effective binding to potassium in pharmacodynamics studies in healthy volunteers. Using its unique chemistry, Ardelyx has developed RDX7675 as a patented improvement to sodium polystyrene sulfonate (SPS), an FDA approved polymer that has been the standard-of-care for the treatment of hyperkalemia for more than 50 years. The company made several key physical and chemical modifications to eliminate sodium and sorbitol, optimize binding capacity, greatly improve palatability and develop formulations that would taste pleasant and be easier to ingest. Ardelyx believes these improvements offer unique advantages for patients with hyperkalemia and could increase patient satisfaction and compliance.
Hyperkalemia is defined as the presence of blood potassium levels greater than 5.0 mEq/L. Normal levels are 3.5 to 5.0 mEq/L. When hyperkalemia is severe, or above 7.0 mEq/L, there is a significantly increased risk of death because of the potential for heart conductance problems.
