Ardelyx has completed three successful Phase 3 pivotal trials, and an additional clinical trial (OPTIMIZE) for Tenapanor
Key Point –
First patient reported outcome data on Tenapanor from OPTIMIZE trial demonstrates improved overall patient experience and benefit of one pill twice daily dosing regimen with Tenapanor compared to binder therapies
– Post-hoc analysis shows comparable phosphate lowering in patients undergoing hemodialysis (HD) and peritoneal dialysis (PD) with a mean change from baseline to week 26 of -1.70 mg/dL in PD group
– Additional post-hoc analysis shows that in a subset of patients with severe hyperparathyroidism, tenapanor lowers parathyroid hormone and fibroblast growth factor 23 levels
– Tenapanor novel mechanism of action shown to selectively decrease serum phosphorus by inhibiting paracellular phosphate absorption, without impacting other serum electrolytes (sodium, bicarbonate, chloride, potassium, calcium, magnesium) or albumin
Ardelyx, Inc, a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, on November 5th announced multiple presentations covering additional positive clinical observations with Tenapanor at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week).
Ardelyx has completed three successful Phase 3 pivotal trials, and an additional clinical trial (OPTIMIZE) for Tenapanor, an investigational, first-in-class phosphate absorption inhibitor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor was discovered and developed by Ardelyx.
First patient reported outcome data on Tenapanor from OPTIMIZE trial demonstrates improved overall patient experience and benefit of one pill twice daily dosing regimen with Tenapanor compared to binder therapies. Post-hoc analysis shows comparable phosphate lowering in patients undergoing hemodialysis (HD) and peritoneal dialysis (PD) with a mean change from baseline to week 26 of -1.70 mg/dL in PD group. Additional post-hoc analysis shows that in a subset of patients with severe hyperparathyroidism, Tenapanor lowers parathyroid hormone and fibroblast growth factor 23 levels. Tenapanor novel mechanism of action shown to selectively decrease serum phosphorus by inhibiting paracellular phosphate absorption, without impacting other serum electrolytes (sodium, bicarbonate, chloride, potassium, calcium, magnesium) or albumin
“These data provide additional perspective on the potential benefits of Tenapanor and further support its utility in the management of serum phosphorus,” said Laura Williams, chief medical officer for Ardelyx. “We continue to pursue approval of this first-in-class, novel therapy which we believe represents an important innovation for the nephrology community.”
Ardelyx is developing Tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease, and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.
“As a person living with kidney disease who has struggled with managing phosphorus, it gives me great hope to see the patient perspective and patient priorities being incorporated into clinical studies,” said Derek Forfang, chair, NKF Kidney Patient Advocacy Committee and co-chair, Forum of ESRD Networks’ Kidney Patient Advisory Council. “The OPTIMIZE results suggest that Tenapanor could have an enormous positive impact on the health and quality of life of many patients on dialysis through its novel mechanism that blocks, not binds, phosphorus. Tenapanor has the potential to help more patients achieve target phosphorus levels and reduce the treatment burden associated with currently available hyperphosphatemia therapies. The incorporation of the patient voice into the clinical trial design and evaluation of Tenapanor is a huge step forward for patients.”
Pablo E. Pergola, director, Clinical Advancement Center, Renal Associates PA, San Antonio, Texas, added, “These data for Tenapanor reported at ASN reveal new important observations, including its efficacy in both peritoneal dialysis and hemodialysis, its ability to lower PTH and FGF23 levels, and its lowering of serum phosphorus without affecting other electrolytes. In addition, the new data reported from the OPTIMIZE trial provides a first glimpse into the real-world use of Tenapanor, showing its ability not only to help more patients achieve target phosphorus levels, but also its ability to improve the patient experience regarding the management.
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