US-based clinical-stage company Ardelyx has begun a Phase III clinical trial and another onset-of-action clinical trial of RDX7675 to treat hyperkalemia.
RDX7675 is an orally administered, non-absorbed potassium-binding polymer, which binds to potassium in pharmacodynamics studies in healthy volunteers.
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It has been developed as a patented improvement to sodium polystyrene sulfonate (SPS), a US Food and Drug Administration (FDA) approved polymer regarded as the standard-of-care to treat hyperkalemia.
Its composition features physical and chemical modifications to eliminate sodium and sorbitol, as well as optimise binding capacity while making the product taste pleasant.
The Phase II trial will be conducted as a randomised, single-blind, three-part study intended to test the safety and efficacy of RDX7675 while examining about 300 adult patients with hyperkalemia. The study also includes a long-term, open-label safety extension.
The onset-of-action trial will be carried out as a single-blind, placebo controlled study, which will test the onset-of-action, safety and efficacy of RDX7675 in 60 patients with hyperkalemia.
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By GlobalDataArdelyx CEO Mike Raab said: "The Phase III study for hyperkalemia marks the start of the fifth Phase III clinical trial from our pipeline of internally developed, gut-restricted treatments in development.
"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 III 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 are not satisfied with their current care.”
The company is expected to release data from the onset-of-action study in the first half of this year.
