Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), has initiated four Phase 3 clinical studies in Japan evaluating tenapanor for hyperphosphatemia. The achievement of this development milestone triggers a $5 million payment to Ardelyx.
The Phase 3 clinical trials consist of a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparative study; a phosphate binder-combination parallel-group comparative study; an open-label, single-arm study evaluating hyperphosphatemia patients on peritoneal dialysis; and a long-term study evaluating serum phosphorus in patients who switch from one or more phosphate binders to tenapanor for hyperphosphatemia in Japan.
"As we approach our April 29 PDUFA date for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis and prepare for potential commercialization in the U.S., we are pleased to see the significant progress made by our partner Kyowa Kirin," said Mike Raab, president and chief executive officer of Ardelyx. "We are thrilled to have key strategic partners like Kyowa Kirin, along with our partners in Canada and China, to support development of, and once approved, patient access to, tenapanor globally."
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Under the terms of the license agreement for tenapanor with Kyowa Kirin, which was signed in 2017 Ardelyx received a $30 million upfront payment and is eligible to receive up to $55.0 million in total development milestones and 8.5 billion yen in commercialization milestones. Ardelyx is also eligible to receive high-teen royalties on sales throughout the term of the agreement. Kyowa Kirin has been granted the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.
About Tenapanor for Hyperphosphatemia
Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, oral medicine for which an NDA is under review by the FDA for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. Ardelyx is conducting NORMALIZE, an ongoing extension study of the PHREEDOM Phase 3 monotherapy study, which is designed to evaluate the ability of tenapanor, as monotherapy or in combination with sevelamer, to achieve serum phosphorus levels in the normal range (2.5 – 4.5 mg/dL) in patients with chronic kidney disease (CKD) on dialysis. Planned analyses have demonstrated that the use of tenapanor as a foundational approach, as monotherapy or in combination with sevelamer carbonate, produces a significant phosphorus-lowering effect. After ~ 20 months of treatment with tenapanor alone or with low doses of sevelamer, patients exhibited a mean serum phosphorus reduction of 2.33 mg/dL, from a mean baseline phosphorus of 7.27 mg/dL at the beginning of the PHREEDOM trial to a mean of 4.94 mg/dL.
Date: Apr 14, 2021
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