Alebund Pharmaceuticals has announced positive topline Phase III results highlighting that the use of AP301 has demonstrated a statistically significant and clinically meaningful improvement in serum phosphorus control in dialysis patients with hyperphosphatemia (HP). GlobalData believes that this study could be of high clinical value to nephrologists seeking an optimal treatment of choice for HP patients. If approved, AP301 could address two significant issues in HP management: poor patient adherence and inadequate phosphorus control.
HP is one of the most common complications in chronic kidney disease patients. AP301 acts as a phosphate binder. Phosphate binders help to pass excess phosphate out of the body in the stool, reducing the amount of phosphate that enters the blood.
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The Phase III trial was a randomised, open-label, multicentre study. Topline results showed a statistically significant and clinically meaningful improvement in serum phosphorus control versus sevelamer carbonate across 474 dialysis patients over 52 weeks. The safety profile of AP301 was also found to be favourable and consistent with previous findings.
Results from the trial are significant as they confirm that a swallowable, low-pill, non-absorbed iron polymer can match or exceed sevelamer in phosphate control while tackling the adherence hurdles that HP patients face. Despite the promising clinical data on AP301, the drug is expected to enter the mature dialysis market and will likely face notable barriers against marketed iron-based binders Velphoro (sucroferric oxyhydroxide) and Auryxia (ferric citrate), as well as the dominant cheaper calcium-based binders.
Shanghai Alebund Pharmaceuticals Ltd is a biopharmaceutical company headquartered in Shanghai, China, developing therapies for the treatment of renal diseases and related chronic conditions. According to GlobalData’s Drugs Database, AP301 is currently in Phase III for the US and Chinese markets. As detailed results are presented at upcoming medical conferences, AP301’s data will likely establish new benchmarks for efficacy-convenience balance in HP management.
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