New updates have been reported about Alebund Pharmaceuticals (PC:ALEBU)
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Alebund Pharmaceuticals has unveiled pivotal phase 3 trial results for its innovative phosphate binder, AP301, at the American Society of Nephrology 2025 Congress. The study, conducted across 50 sites in China, demonstrated AP301’s efficacy in reducing serum phosphate levels in dialysis patients with hyperphosphatemia. Notably, AP301 showed non-inferiority to sevelamer carbonate, a standard treatment, and maintained its effectiveness over a 52-week period. This novel fiber-iron-based binder offers advantages such as reduced pill burden and improved patient adherence, without systemic absorption or the need for chewing.
The RESPOND-1 study involved 474 randomized participants, with AP301 proving superior in maintaining serum phosphate control compared to a low dose. The trial highlighted AP301’s safety profile, with common adverse effects like diarrhea resolving without treatment changes. Alebund’s Chief Medical Officer, Dr. Jin Tian, emphasized the potential of AP301 to enhance treatment options for hyperphosphatemia, a common complication in chronic kidney disease patients. Alebund is actively engaging with Chinese regulatory authorities for the drug’s approval, aiming to address the significant unmet need in phosphate management. With the Chinese market for phosphorus-lowering products projected to reach RMB10 billion by 2035, AP301 could play a crucial role in improving patient outcomes and expanding Alebund’s footprint in renal disease therapeutics.