Ardelyx Presents New Preclinical Data Demonstrating Synergy between Tenapanor and Sevelamer When Dosed in Combination for Elevated Serum Phosphorus
FREMONT, Calif., /PRNewswire/ -- Ardelyx Inc. (Nasdaq: ARDX), today announced the presentation of preclinical data suggesting therapeutic synergy of tenapanor in combination with sevelamer, the current standard-of-care phosphate binder treatment for hyperphosphatemia, or elevated serum phosphorus. The data, showing that the combination meaningfully reduced serum phosphorus, were presented today in a poster titled "Combination treatment with tenapanor and sevelamer synergistically reduces urinary phosphorus excretion in rats," at the American Society of Nephrology (ASN) Annual Meeting. Tenapanor, Ardelyx's lead product candidate, is a sodium/hydrogen exchanger 3 (NHE3) inhibitor that is currently being evaluated as a monotherapy in a second, Phase 3 registration trial, the PHREEDOM trial, for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis. Data from that study are anticipated in 2019.
The preclinical data presented today support Ardelyx's plans to evaluate tenapanor in combination with phosphate binders in a planned Phase 2/3 clinical trial. During the treatment period of the planned Phase 2/3 combination trial, patients will remain on their binders with either tenapanor or a placebo added to their treatment regimen.
"If we are able to replicate what we've seen in these preclinical studies in our planned human studies, we believe tenapanor could be used as an add-on to current binder therapy," said David P. Rosenbaum, chief development officer of Ardelyx. "Most dialysis patients have phosphate levels that are significantly higher than normal, but to date, the only options for treatment have been to add more phosphate binders, which all have similar mechanisms of binding to dietary phosphate in the gastrointestinal tract. Given the uniquely different mechanism of tenapanor and its potential synergy with phosphate binders, we could imagine nephrologists adding tenapanor to the phosphate binder regimen of their patients, potentially improving phosphate management and reducing the pill burden of phosphate binders. We are excited to see if this effect is supported by our planned human study."
In preclinical models, sevelamer was administered at three dose levels with either tenapanor or placebo added twice daily for 11 days. Two additional groups received either tenapanor or placebo alone. Results showed that in combination with tenapanor, sevelamer dose-dependently decreased urinary phosphorus excretion and reduced renal phosphorus clearance, resulting in a treatment effect that was greater than either tenapanor or the equivalent dose of sevelamer administered alone across all sevelamer dose levels, or the expected additive reduction of the two treatments combined. Treatment with tenapanor significantly decreased urinary sodium excretion versus placebo, both when administered alone and when co-administered with all doses of sevelamer. In addition, treatment with tenapanor alone significantly reduced renal sodium clearance versus placebo, a reduction that was not significantly affected by combination treatment with sevelamer at the two lower doses. Notably, the combination effect of tenapanor and sevelamer on urinary phosphorus excretion was synergistic, with the strongest synergy at the lowest and most clinically relevant sevelamer dose.
About Ardelyx, Inc.
Forward Looking Statements
View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-presents-new-preclinical-data-demonstrating-synergy-between-tenapanor-and-sevelamer-when-dosed-in-combination-for-elevated-serum-phosphorus-300738631.html
Company Codes: NASDAQ-NMS:ARDX