Alebund Pharmaceuticals has completed patient enrolment in its global Phase III pivotal clinical trial, RESPOND-2, Study AP301-HP-03, evaluating the fibre-iron-based phosphate binder AP301 for hyperphosphatemia.
The multi-regional, randomised, double-blind trial enrolled 282 chronic kidney disease patients on maintenance dialysis, with 138 participants in the US and 144 in China.
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Dr Geoffrey Block from US Renal Care is leading the trial while Zhongshan Hospital, Fudan University nephrology department director Xiaoqiang Ding is serving as the principal investigator for China.
Designed as a next-generation therapy, AP301 aims to provide enhanced phosphate-binding, improved gastrointestinal tolerability, minimal iron overload risk, and no need for pre-swallow chewing.
The therapy is designed to improve adherence and offer effective control of serum phosphate.
The study involved CKD patients aged 12 years and above, enrolling 282 patients instead of the planned 264.
It comprises three phases: an eight-week double-blind dose titration (AP301 versus AP301 ineffective low dose in a 2:1 randomisation), a 24-week open-label treatment phase, and a three-week double-blind randomised withdrawal phase (1:1 re-randomisation).
The primary endpoint measures the change in serum phosphate from baseline to the end of dose titration. The key secondary endpoint tracks the change in serum phosphate after the open-label and withdrawal phases.
Existing data led to the US Food and Drug Administration (FDA) agreement that this global study can serve as the single pivotal registration trial for AP301 in the US.
Alebund plans a new drug application submission in China based on outcomes from the earlier pivotal Phase III trial, RESPOND-1, Study AP301-HP-02, and other accumulated results.
Alebund Pharmaceuticals co-founder and chief medical officer Jin Tian said: “The on-time completion of patient enrolment in AP301’s global Phase III pivotal multi-regional clinical trial reflects Alebund’s ability to advance high-quality global clinical development, which is an important milestone in the global registrational development of AP301.”
