Alebund Completes Global Phase III Enrollment for AP301 in Hyperphosphatemia Push

New updates have been reported about Alebund Pharmaceuticals.

Alebund Pharmaceuticals has completed patient enrollment in RESPOND-2, its global Phase III pivotal, multi-regional trial of AP301, a next-generation fiber-iron phosphate binder for hyperphosphatemia in dialysis patients. The study, run in the U.S. and China with 282 chronic kidney disease patients on maintenance dialysis, is designed as the single registrational trial to support U.S. approval following alignment with the FDA.

RESPOND-2 uses a three-stage design with an initial 8-week double-blind titration, a 24-week open-label phase, and a 3-week randomized withdrawal period, with primary and key secondary endpoints focused on changes in serum phosphate under AP301 versus an ineffective low dose. AP301 aims to offer higher phosphate-binding capacity, better gastrointestinal tolerability, lower iron overload risk, and easier administration than current agents, targeting improved adherence and more consistent phosphate control.

For China, Alebund has already generated pivotal evidence from RESPOND-1, a 52-week Phase III trial in 474 patients at 50 sites, where AP301 matched sevelamer carbonate at 12 weeks and delivered superior phosphate control versus low dose at 27 weeks. By week 52, AP301 showed slightly greater mean phosphate reduction, higher target attainment (66.7% versus 58.6%), and a lower daily dose versus sevelamer, supporting its potential long-term therapeutic and competitive advantage.

Safety data from RESPOND-1 showed AP301 was generally well tolerated, with discolored feces and mild, early-onset diarrhea as the main adverse events and no signal of iron accumulation over 52 weeks, underpinning its risk-benefit profile for regulatory review. Leveraging these results and accumulated clinical data, Alebund has secured alignment with China’s NMPA and plans to submit a New Drug Application in the near term, positioning AP301 as a potential new standard therapy in a market where phosphate control rates remain suboptimal.

Alebund’s leadership highlights on-time global enrollment as a key milestone in demonstrating the company’s capability to execute high-quality international development programs, a critical asset for a late-stage renal portfolio. With the Chinese hyperphosphatemia market projected to reach RMB 10 billion and the global market about USD 6 billion by 2035, AP301 could become a cornerstone asset for Alebund, supported by its new Yangzhou manufacturing site and in-house commercialization team focused on renal indications.

Founded in 2018 and headquartered in Shanghai, Alebund has built a pipeline of seven drug candidates and one commercial product targeting CKD and related complications, including hyperphosphatemia, renal anemia, IgA nephropathy, diabetic kidney disease, FSGS, and ADPKD. Successful U.S. and China approvals for AP301 would not only address a major unmet need—where less than half of dialysis patients achieve phosphate targets—but also materially enhance Alebund’s revenue visibility, global footprint, and strategic position in kidney disease therapeutics.