#China #Houston #Alebund #AP301 #Hyperphosphatemia

Alebund Unveils Phase 3 Trial Results of AP301

Alebund Pharmaceuticals recently showcased the results of its Phase 3 clinical trial for AP301 at the American Society of Nephrology (ASN) 2025 Congress held in Houston, Texas. This pivotal study evaluated the efficacy and safety of AP301, a novel iron-based phosphate binder, in patients undergoing dialysis who suffer from hyperphosphatemia—a condition characterized by elevated serum phosphate levels that can lead to severe complications.

Key Findings: Clinical Superiority Validated

The trial, officially known as the RESPOND-1 study, involved a robust cohort of individuals on hemodialysis and peritoneal dialysis, addressing a critical need in managing phosphate control in chronic kidney disease (CKD) patients. AP301 demonstrated a clinically significant advantage over a conventional low dose, significantly lowering serum phosphate levels over the study's duration.

The non-inferiority of AP301 compared to sevelamer carbonate was established, supporting its potential as a new therapeutic option for patients who typically struggle with high serum phosphate levels despite existing treatments. Notably, the AP301 maintenance dose proved effective throughout the 52 weeks of treatment, reinforcing its long-term benefits.

Study Design and Outcomes

Conducted across 50 investigational sites in China, the study enrolled 474 randomized participants. It featured an active control phase where participants received sevelamer carbonate and an AP301 low-dose control phase. The trial ultimately found that AP301 led to a statistically significant decrease in serum phosphate levels compared to the ineffective low dose.

Over the course of the study, AP301 not only matched the efficacy of sevelamer carbonate but also outperformed it in certain aspects. At Week 27, the AP301 maintenance dose showcased a clinically relevant superiority over the low dose group with a significant reduction in serum phosphate levels (-0.58 mmol/L). The study results indicated that 66.7% of participants in the AP301 arm achieved notable phosphate control, compared to 58.6% in the sevelamer carbonate arm, all while administering a lower daily dose of the phosphate binder.

Safety Profile and Adverse Effects

Alebund's Phase 3 trial also highlighted the safety profile of AP301, reporting that it was well-tolerated among participants. While the majority experienced some adverse events (AEs), including diarrhea and discolored feces, these symptoms were mostly mild and resolved without necessitating treatment changes. Importantly, no signs of iron accumulation were observed throughout the cumulative exposure to AP301, addressing a significant concern for patients requiring long-term medication.

Implications for Future Therapy

Dr. Jin Tian, Chief Medical Officer at Alebund, emphasized the study's importance in advancing treatment for hyperphosphatemia, stating, "AP301 is differentiated from other iron-based phosphate binders due to its unique properties such as no systemic absorption and ease of use. We believe that this trial may pave the way for enhanced phosphate management in dialysis patients."

In addressing the significant rates of uncontrolled serum phosphate levels in dialysis patients—reported to be exacerbated in China compared to global statistics—Alebund recognizes the critical need for improved treatment options. With an expected market growth for phosphate-lowering products in China to reach RMB 10 billion by 2035, Alebund is strategically positioned to innovate in this space.

The company is currently collaborating with the China National Medical Products Administration to expedite the new drug application process for AP301, hoping to bring this novel therapy to market for patients in need.

As Alebund continues to develop breakthrough therapies for renal diseases, including an extensive pipeline targeting chronic conditions, the findings from this Phase 3 trial signify a promising step toward providing patients with more effective treatment alternatives for hyperphosphatemia.