Ardelyx (ARDX) Announces FDA Approval of XPHOZAH

Ardelyx, Inc. (Nasdaq: ARDX) today announced that the U.S. Food and Drug Administration (FDA) has approved XPHOZAH® (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

“The approval of XPHOZAH is an important milestone for patients on dialysis, their families and the nephrology care community, as it represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus. It is also a significant accomplishment for everyone at Ardelyx,” said Mike Raab, president and chief executive officer of Ardelyx. “Since the founding of the company in 2007, we have been steadfast in our commitment to the kidney community, and today’s approval reinforces the compelling clinical profile and potential benefit that XPHOZAH may provide for so many patients. This therapy was born in our labs in 2008, and to now see it becoming available for patients is truly a testament to the dedication, outstanding execution, and sense of mission of the Ardelyx team. This approval is also a tribute to the patients, families, physicians and clinical trial personnel who participated in the development of XPHOZAH. There is a high level of anticipation and enthusiasm for the launch of XPHOZAH from the kidney community, and our world-class team will enter the marketplace well positioned with a first-in-class product.”

Dr. Glenn Chertow, professor of medicine, Stanford University, added, “Hyperphosphatemia management has been a persistent clinical challenge, as the majority of patients receiving maintenance dialysis are unable to consistently achieve target serum phosphate concentrations despite treatment with phosphate binders. XPHOZAH is not a phosphate binder. XPHOZAH is a phosphate absorption inhibitor. In patients not adequately responding to phosphate binder therapy, XPHOZAH has been shown to help increase the proportion of patients achieving target serum phosphate concentrations. I believe XPHOZAH can advance the care of patients with hyperphosphatemia, providing a new treatment option with a complementary mechanism of action.”

Clinical Data Supporting XPHOZAHFDA approval of XPHOZAH is based on a comprehensive development program, including a diverse population of more than 1,000 patients in three Phase 3 clinical trials evaluating the efficacy and safety of XPHOZAH, as monotherapy and in combination with phosphate binder therapy, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY). Data from the three clinical trials demonstrated that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.

Diarrhea, which occurred in 43 to 53 percent of patients, was the only adverse reaction reported in at least five percent of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in five percent of XPHOZAH-treated patients in these trials.

Ardelyx also completed two open-label clinical trials (OPTIMIZE and NORMALIZE) to evaluate different options for integrating XPHOZAH into clinical practice.

Ardelyx Commitment to Patient AccessArdelyx is committed to setting new standards in product innovation and to setting new standards for patient support. Ardelyx will integrate XPHOZAH into its established patient services program, ArdelyxAssist™. ArdelyxAssist is an innovative, digital-forward patient services program that provides access and affordability support for patients, with integration into medical office work processes and connectivity to patients and health care providers.

Conference Call DetailsThe company will host a conference call tomorrow, October 18, 2023, at 8:00 am ET to discuss today's announcement. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, www.ardelyx.com, and will be available on the website for 30 days following the call.

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