Alebund Pharmaceuticals announced positive topline phase III results highlighting that the use of AP301 demonstrated a statistically significant and clinically meaningful improvement in serum phosphorus control in dialysis patients with hyperphosphatemia (HP). If approved, AP301 could potentially address two unmet needs in HP management: poor patient adherence and inadequate phosphorus control, says GlobalData, a leading data and analytics company.

The phase III trial was a randomized, open-label, multi-center study. Topline results showed that there was a statistically significant and clinically meaningful improvement in serum phosphorus control versus sevelamer carbonate across 474 dialysis patients over 52 weeks. In addition, the safety profile of AP301 was found to be favorable and consistent with previous findings.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments: “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 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 to entry against marketed iron-based binders Velphoro (sucroferric oxyhydroxide) and Auryxia (ferric citrate), as well as the dominant cheaper calcium-based binders.”

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 gets into blood.

Jaddoo concludes: “According to GlobalData’s Drugs Database, AP301 is currently in phase III for the US and China market. As detailed results are presented at upcoming medical conferences, AP301’s data will likely establish new benchmarks for efficacy-convenience balance in HP management.”