Libang Pharmaceutical-B (09637): The global phase IIb multi-regional clinical trial of ap306 for hyperphosphatemia in patients undergoing maintenance hemodialysis completed the first randomization and administration of patients on maintenance hemodialysis

Zhitong Finance App News, Rebang Pharmaceutical-B (09637) announced that AP306's global phase IIb multi-regional clinical trial (ClinicalTrials.gov registration number: NCT06712654) for patients with hyperphosphatemia undergoing maintenance hemodialysis has completed randomized enrollment and administration of the first test subjects. Phase IIb trials are being conducted at multiple clinical centers in the US and China.

The phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and reduction of serum phosphorus in patients with hyperphosphatemia receiving maintenance hemodialysis with a fixed dose of AP306.

The phase IIb trial plans to recruit approximately 168 subjects and randomly assign them to six AP306 fixed-dose regimens or placebo groups for a treatment period of eight weeks. The primary endpoints were changes in serum phosphorus levels from baseline to end of treatment. Secondary endpoints included the proportion of subjects who reached the target blood phosphorus range and the time to achieve blood phosphorus control. The main findings (top-line data) of the phase IIb trial are expected to be announced in the first half of 2027.