Global Phase IIb multi-regional clinical trial for AP306, targeting hyperphosphatemia in patients on maintenance hemodialysis, has achieved a significant milestone with the first patient randomized and dosed.

ALEBUND-B (ASX: 09637) announced the progress for its investigational drug AP306, which is being evaluated in a trial registered under ClinicalTrials.gov identifier NCT06712654.

The Phase IIb study is currently being conducted across multiple clinical sites in the United States and China.

This phase of the trial is designed as a multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of fixed-dose AP306 in reducing serum phosphorus levels in the target patient population.

The trial plans to enroll approximately 168 participants, who will be randomly assigned to one of six fixed-dose AP306 regimen groups or to a placebo group for an eight-week treatment period.

The primary endpoint of the study is the change in serum phosphorus levels from baseline to the end of the treatment period.

Key secondary endpoints include the proportion of subjects achieving the target serum phosphorus range and the time taken to achieve phosphorus control.

Topline results from this Phase IIb clinical trial are anticipated to be announced in the first half of 2027.