Ardelyx's lead drug tenapanor scores in second hyperphosphatemia study, shares leap
As the FDA’s decision date on Ardelyx’s lead drug, tenapanor, for use in irritable bowel syndrome looms — the California drug developer unveiled positive data from a late-stage study testing the small molecule in patients with chronic kidney disease (CKD).
The drug, which is engineered to target NHE3 transporter in the gut to promote tightening of epithelial cell junctions and excretion of excess phosphate, was tested in combination in CKD patients on dialysis whose hyperphosphatemia is not under control with binders alone.
The trial, called AMPLIFY, enrolled 236 patients with CKD on dialysis, who had elevated phosphate levels despite a binder regimen. Baseline serum phosphorus at randomization was at a mean level of 6.8 mg/dL.
The results were positive all around: The drug met the main goal, as well as all the secondary endpoints. The company’s shares $ARDX jumped about 28% to $4.35 before the bell on Tuesday.
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