Benzinga | Oct 22, 2020 10:01AM EDT

Ardelyx, Kyowa Kirin Highlight New Clinical Data Presented Within 5 Posters For Kidney Week 2020

Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company developing targeted, first-in-class medicines to improve the lives of patients with kidney and cardiovascular diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today highlighted new clinical data presented within five posters at Kidney Week 2020, this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway.



Of the posters presented today, three highlight tenapanor clinical data from Ardelyx's Phase 3 trials in the U.S., including the BLOCK, AMPLIFY, and PHREEDOM studies, while two present results from the Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis conducted by Kyowa Kirin, to whom Ardelyx has licensed exclusive rights to develop and commercialize tenapanor in Japan for the treatment of cardiorenal diseases. In Japan, Kyowa Kirin has conducted three Phase 2 trials of tenapanor as KHK7791. Tenapanor, which was discovered and developed by Ardelyx, is a first-in-class therapy currently under review for potential marketing approval by the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Kevin Martin, MD, Professor of Internal Medicine and Director, Division of Nephrology, Saint Louis University commented: "Despite the serious cardiovascular consequences of elevated phosphorus levels, and the development of a variety of phosphate binders, we have made little progress in achieving sustained control of hyperphosphatemia over the past 30 years. Recent advances in our mechanistic understanding of phosphate absorption have led to a whole new way of thinking about how to manage hyperphosphatemia. With its novel mechanism of action targeting paracellular phosphate transport and comprehensive clinical data continuing to support its efficacy and safety, I believe tenapanor, if approved, has the potential to truly transform the management of hyperphosphatemia."

Ardelyx Poster Presentations:

* ePoster #PO0384, entitled "Long-term Safety and Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis," further summarizes data from PHREEDOM, a long-term Phase 3 U.S. study evaluating the safety and efficacy of tenapanor for the control of serum phosphorus in patients with CKD on dialysis. New details presented demonstrate that, within the efficacy analysis set, treatment with tenapanor resulted in sustained reductions in serum phosphorus concentrations, decreasing mean serum phosphorus from 7.7 mg/dL at baseline to 5.1 mg/dL at the end of the randomized treatment period.

* ePoster #PO0374, entitled "Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis: Novel Mechanism of Action Allows for Both Monotherapy and Dual Mechanism Approach," presents clinical data from two Phase 3 clinical trials, demonstrating that tenapanor reduces serum phosphorus when used as monotherapy in hyperphosphatemia patients with CKD on dialysis (BLOCK trial) and reduces serum phosphorus levels in patients with difficult-to-control hyperphosphatemia when used with phosphate binders as part of a dual-mechanism approach (AMPLIFY trial). The poster highlights the need for new strategies to manage hyperphosphatemia and suggests that tenapanor, with its novel mechanism of action, could offer a new treatment approach for patients with CKD on dialysis.

* ePoster #PO0376, entitled "Tolerability of Tenapanor, an Investigational, First-in-Class, Non-Binder Therapy for the Control of Serum Phosphorus in Patients with CKD on Dialysis," presents an in-depth analysis of the tolerability profile of tenapanor across three pivotal clinical studies, BLOCK, PHREEDOM, and AMPLIFY, concluding that tenapanor was generally well tolerated in all studies and that the overall gastrointestinal tolerability of tenapanor is consistent with its novel mechanism of action.

Kyowa Kirin Poster Presentations:

* ePoster #PO0382, entitled "Dose-Response Efficacy and Tolerability of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 2 Study," concludes that tenapanor significantly decreased serum phosphorus levels in a dose-dependent manner, and was generally well tolerated across doses in Japanese patients. Compared to placebo, the 30mg BID dosing groups produced a statistically significant 2.6 mg/dL mean reduction (p<0.001) in serum phosphorus from baseline to the end of the six-week treatment period.

* ePoster #PO0375, entitled "Efficacy and Safety of Add-on Tenapanor to Phosphate Binders for Refractory Hyperphosphatemia in Japanese Patients on Hemodialysis: A Phase 2, Double-Blind Study," concludes that, the efficacy and safety of tenapanor with phosphate binders was consistent with other studies conducted in Japan where tenapanor was administered as a single agent. Compared to placebo and phosphate binders, treatment with tenapanor and phosphate binders achieved a statistically significant 2.1 mg/dL mean reduction (p<0.001) in serum phosphorus, with 87% of patients in the tenapanor group achieving target phosphorus levels.

All poster presentations are now publicly available and can be accessed on demand HERE.

In addition to the poster presentations during the ASN Annual Meeting, an Exhibitor Spotlight presentation, sponsored by Ardelyx, provides information on advances in the science of phosphate absorption and clinical data on tenapanor:

"ADVANCING THE SCIENCE OF PHOSPHATE ABSORPTION: Paracellular Pathway and Implications for Phosphorus Management." Guest speakers focus on the following topics:

* New Understanding of Phosphate Absorption May Explain Challenges in Phosphorus Management PRESENTED BY: KAMYAR KALANTAR-ZADEH, MD, MPH, PhD, Professor of Medicine, Pediatrics, Public Health, Epidemiology, and Nursing Sciences, Chief, Division of Nephrology and Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine

* Tenapanor: An Investigational Therapy for the Treatment of Hyperphosphatemia PRESENTED BY: GLENN M. CHERTOW, MD, MPH, Chief, Division of Nephrology Stanford University School of Medicine

To view the full presentation, click on the Ardelyx Exhibitor Spotlight program HERE.