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Peyton Onfijo

Research Analyst at TD Cowen

Peyton Onfijo's questions to ARDELYX (ARDX) leadership

Question · Q4 2025

Peyton Onfijo from TD Cowen asked about the powering of the CIC trial and the targeted proportion of patients expected to be CSBM responders.

Answer

Chief Patient Officer and Interim Chief Medical Officer Laura Williams stated that the ACCEL trial is robustly powered at 95% with a planned enrollment of approximately 700 patients across four treatment arms (three active doses and placebo). Based on TEMPO study data, the trial is designed to detect an 18-20% difference in durable CSBM responder rates between placebo and the active 25mg and 50mg doses.

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