AZ licences renal disease compound
pharmafile | October 9, 2012 | News story | Research and Development, Sales and Marketing | Ardelyx, AstraZeneca, NHE3
AstraZeneca has signed an agreement giving it worldwide exclusive rights to California-based Ardelyx’s NHE3 inhibitor programme targeting liver and kidney conditions.
The manufacturer is paying $35 million up front and could add $237.5 million to that in milestones as well as tiered, double-digit royalties.
Ardelyx’s programme is aimed at producing treatments for complications associated with end-stage renal disease (ESRD) and chronic kidney disease (CKD).
For its money AstraZeneca will have access to Ardelyx’s lead compound, RDX5791, which has also been looked at in a Phase IIa clinical trial in constipation-predominant irritable bowel syndrome (IBS-C).
NHE3 is the sodium–hydrogen antiporter 3, a protein essential in absorbing sodium in the intestines, and RDX5791’s mechanism is thought to decrease this absorption. That means it should divert sodium excretion from urine to faeces, with the result that the kidney and cardiovascular system have less exposure to its potentially unhealthy effects.
The investigational compound’s ability to divert sodium absorption in the gastrointestinal tract has been the subject of two Phase I studies in healthy subjects.
“There is a significant unmet medical need to address the challenges caused by sodium and excess fluid in people with renal impairment,” said Gunnar Olsson, head of CVGI innovative medicines at AstraZeneca.
“With a novel mechanism of action, RDX5791 has the potential to have a major impact on how doctors treat these patients,” he added.
The plan is for AstraZeneca and Ardelyx to develop RDX5791 for use in ESRD, CKD and IBS-C, and to look at its development in other diseases in which sodium and fluid overload are a major factor.
AstraZeneca is to cover development costs and Ardelyx will conduct the Phase II trials, as well as having a limited option to co-promote RDX5791 in the US.
“RDX5791 is our first clinical example of how our technology can be used to develop non-absorbed, small molecule therapeutics,” said Ardelyx chief executive Mike Raab. “We are delighted that AstraZeneca recognizes the potential of this compound.”
Ardelyx has other products in early development for type II diabetes and renal disease and has raised $56.0 million in funding since it was founded in 2007.
Adam Hill
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