ALEBUND-B (09637): The first subject has been randomized and treated in the global phase IIb multicenter clinical trial of AP306 for the treatment of hyperphosphatemia in maintenance hemodialysis patients.

ALEBUND-B (09637) has announced that the global Phase IIb multicenter clinical trial (ClinicalTrials.gov registration number: NCT06712654) of AP306 for patients with hyperphosphatemia undergoing maintenance hemodialysis has completed the randomization and dosing of the first subject. The Phase IIb trial is being conducted at multiple clinical centers in the United States and China. The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and efficacy of AP306 at a fixed dose for patients with hyperphosphatemia undergoing maintenance hemodialysis. The Phase IIb trial plans to recruit approximately 168 subjects and randomize them to one of six fixed dose regimens of AP306 or placebo for a treatment period of eight weeks. The primary endpoint is the change in serum phosphorus levels from baseline to the end of treatment, with secondary endpoints including the proportion of subjects achieving target phosphorus levels and the time to achieve phosphorus control. The primary results of the Phase IIb trial (top-line data) are expected to be announced in the first half of 2027.