AstraZeneca Licenses Kidney Disease Complications Treatment

Cross-section of kidney (National Library of Medicine)

AstraZeneca, a global pharmaceutical company based in the U.K., agreed to license a compound to treat complications of chronic and end-stage kidney disease from Ardelyx in Fremont, California. The deal that provides AstraZeneca with an exclusive worldwide license has a value of at least $272.5 million.

Ardelyx develops small molecule drugs that restrict absorption in the gastrointestinal tract. The company’s lead product, RDX5791, is an orally administered sodium transport inhibitor, designed to treat both constipation-predominant irritable bowel syndrome and prevent sodium overload in patients with kidney and heart disease.

RDX5791 aims to decrease the absorption of dietary sodium and thus divert sodium from the kidney and urine to the feces, sparing the kidney and the cardiovascular system from unhealthy exposure of both sodium and fluid accumulation. The compound has been tested a phase 2 clinical trial in constipation-predominant irritable bowel syndrome and in two separate phase 1 clinical studies in healthy subjects for its ability to divert sodium absorption in the gastrointestinal tract.

AstraZeneca and Ardelyx plan to develop RDX5791 to treat end-stage renal disease and chronic kidney disease, in addition to constipation-predominant irritable bowel syndrome. The companies also plan to evaluate the drug’s application to other diseases that result from sodium and fluid overload.

Under the agreement, AstraZeneca will pay Ardelyx $35 million up front, with development and commercialization milestones of $237.5 million, as well as tiered, double-digit royalties. AstraZeneca will assume the subsequent development costs and Ardelyx will conduct phase 2 clinical trials. As part of the deal, Ardelyx will have the option to co-promote RDX5791 in the U.S.

“There is a significant unmet medical need to address the challenges caused by sodium and excess fluid in people with renal impairment,” says AstraZeneca vice-president Gunnar Olsson. “With a novel mechanism of action, RDX5791 has the potential to have a major impact on how doctors treat these patients.”

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