Alebund completes Phase III AP301 trial enrollment, advancing novel hyperphosphatemia treatment toward regulatory submissions, with potential improved efficacy, safety, and patient adherence.
Alebund Pharmaceuticals has announced the successful completion of patient enrollment in its global Phase III pivotal multi-regional clinical trial (RESPOND-2) for AP301, a novel fiber-iron-based phosphate binder designed to treat hyperphosphatemia. This significant milestone brings the biopharmaceutical company, which specializes in innovative therapies for renal diseases, closer to potential regulatory submissions in the United States.
The RESPOND-2 trial, a double-blind, randomized study, was conducted across sites in the United States and China. It successfully enrolled a total of 282 chronic kidney disease (CKD) patients on maintenance dialysis who suffer from hyperphosphatemia, with 138 participants in the U.S. and 144 in China. The trial was overseen by prominent investigators, including Dr. Geoffrey A. Block of U.S. Renal Care and Professor Xiaoqiang Ding from Zhongshan Hospital, Fudan University in China. The study's design incorporates three distinct treatment phases: an 8-week double-blind dose titration period, followed by a 24-week open-label treatment phase, and concluding with a 3-week double-blind randomized withdrawal phase. The primary endpoint of the trial focuses on evaluating the change in serum phosphate levels from baseline by the end of the dose titration phase.
AP301 is being developed as a next-generation treatment for hyperphosphatemia, a serious condition characterized by elevated phosphate levels in the blood, commonly affecting dialysis patients. Uncontrolled hyperphosphatemia can lead to severe health complications. AP301 aims to address current unmet needs in treatment by offering several advantages over existing phosphate binders. These include a higher phosphate-binding capability, improved gastrointestinal tolerability, a minimal risk of iron overload, and the convenience of not requiring chewing before swallowing. These features are anticipated to enhance patient adherence and lead to more effective control of serum phosphate levels.
This global trial builds upon the success of Alebund's previous Phase III trial, RESPOND-1, which was conducted solely in China. RESPOND-1 involved 474 patients across 50 sites and demonstrated AP301's efficacy and safety, meeting its primary endpoint. In RESPOND-1, AP301 showed comparable efficacy to sevelamer carbonate at 12 weeks and superior phosphate control versus a low dose at 27 weeks, with sustained benefits at 52 weeks. Safety data from RESPOND-1 indicated that AP301 was generally well-tolerated, with common side effects being discolored feces and mild, early-onset diarrhea, and importantly, no evidence of iron accumulation over the 52-week period.
The completion of enrollment for RESPOND-2 is a critical step towards bringing AP301 to a broader patient population. For China, Alebund plans to initiate New Drug Application (NDA) discussions with the National Medical Products Administration (NMPA) in the third quarter of 2025, following the positive results from RESPOND-1. The RESPOND-2 trial is specifically designed as the single registrational trial to support U.S. approval, following alignment with the FDA. The successful development and potential market entry of AP301 could have significant industry-specific impacts by introducing a novel and potentially superior treatment option for hyperphosphatemia, improving patient outcomes, and creating a new competitive dynamic in the renal disease therapeutic area.
