PHREEDOM study: Tenapanor effective for hyperphosphatemia in patients on dialysis
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Phase 3 results from the PHREEDOM study demonstrated treatment with tenapanor safely and effectively decreased serum phosphorous in patients with chronic kidney disease on dialysis, according to a press release from Ardelyx Inc.
“These results are very exciting and represent a capstone to our tenapanor clinical development program, which is focused on the development of a new and important therapy for patients with hyperphosphatemia," Mike Raab, president and CEO of Ardelyx, said in the release. "Based on the PHREEDOM data that demonstrate tenapanor as an effective monotherapy, and the previously released AMPLIFY data that demonstrate the benefits of a dual-mechanism approach with tenapanor plus binders in those who require more aggressive phosphate management, it is clear that tenapanor has a role to play in the management of all dialysis patients with hyperphosphatemia.”
For the study, 564 patients were randomized to either tenapanor (for 26 weeks) or sevelamer (52 weeks; safety control arm). Patients taking tenapanor were then randomized to remain on either tenapanor or placebo. The primary endpoint of the study was the difference in change in serum phosphorous from the end of the 26-week treatment period to the endpoint visit in the 12-week withdrawal period, with researchers finding a mean difference in change of -1.4 mg/dL for those taking tenapanor vs. placebo. In addition, during the 26-week treatment period, 77% of tenapanor-treated patients had a decrease in serum phosphorous (mean reduction from baseline, 2 mg/dL).
Regarding safety, researchers found the most common adverse event to be diarrhea (incidence rate, 52.5%), noting that 90% of cases were determined to be mild to moderate. During the 26-week period, 17.2% of patients treated with tenapanor experienced a serious adverse event compared with 22.6% of those treated with sevelamer.
"If approved, tenapanor is poised to change the way we manage hyperphosphatemia in patients on dialysis," Myles Wolf, MD, MMSc, professor of medicine and chief of Duke Nephrology, said in the release. "Tenapanor would be a first-in-class therapy that targets the primary pathway of phosphate absorption to significantly lower serum phosphate while requiring patients to take just one small pill twice per day. This would make tenapanor an important innovation and potentially an ideal first-line therapy for patients receiving dialysis for whom new effective treatments are desperately needed."
According to Raab, Ardelyx intends to submit a new drug application in mid-2020.
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