Ardelyx announced the presentation of preclinical data suggesting therapeutic synergy of tenapanor in combination with sevelamer, the current standard-of-care phosphate binder treatment for hyperphosphatemia, or elevated serum phosphorus. The data, showing that the combination meaningfully reduced serum phosphorus, were presented today in a poster titled “Combination treatment with tenapanor and sevelamer synergistically reduces urinary phosphorus excretion in rats,” at the American Society of Nephrology Annual Meeting. Tenapanor, Ardelyx’s lead product candidate, is a sodium/hydrogen exchanger 3 inhibitor that is currently being evaluated as a monotherapy in a second, Phase 3 registration trial, the PHREEDOM trial, for the treatment of hyperphosphatemia in patients with end-stage renal disease who are on dialysis. Data from that study are anticipated in 2019. The preclinical data presented support Ardelyx’s plans to evaluate tenapanor in combination with phosphate binders in a planned Phase 2/3 clinical trial. During the treatment period of the planned Phase 2/3 combination trial, patients will remain on their binders with either tenapanor or a placebo added to their treatment regimen.
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