SHANGHAI, June 26, 2025 /PRNewswire/ -- Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of oral iron-based phosphate binder, in dialysis patients with hyperphosphatemia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in serum phosphorus control with AP301. The safety profile of AP301 is favorable and consistent with previous studies.
As a novel fiber-iron-based phosphate binder, AP301 provides high phosphate-binding capability, no need to chew before swallow, no volume expansion when exposed to gastric fluid, and no systemic absorption. These properties contribute to a reduced pill burden, good tolerability and improved patient compliance.
The pivotal study (NCT07030595, CTR20231624) is a randomized, open-label, active-controlled, multi-center phase 3 study designed to evaluate the efficacy and safety of AP301 in controlling serum phosphorus levels in dialysis patients with hyperphosphatemia. The 52-week study contains an active control phase, an AP301 low-dose control phase and an extended treatment phase. Sevelamer carbonate served as the active comparator throughout the whole study period. A total of 474 participants were randomized across 50 investigational sites in China; the study was led by Professor Li ZUO, Director of the Department of Nephrology at Peking University People's Hospital.
"We are deeply grateful to all the participants, investigators, and study personnel for their strong commitment and dedication to this phase 3 study over the past 2 years." Dr. Jin Tian, Co-founder and CMO of Alebund commented, "In the completed phase 2 study, AP301 was shown to be safe, well tolerated, and can effectively lower serum phosphorus in a dose-dependent manner [1]. This pivotal trial further demonstrates the clinical value of AP301, which has the potential to advance the treatment option for millions of patients with hyperphosphatemia through further increasing their adherence."
Alebund plans to engage with China National Medical Products Administration (NMPA) regarding its new drug application plan in the third quarter of 2025. Detailed results from this phase 3 study will be presented at an upcoming medical conference.
Reference
[1] Bing Zhuang, Liangying Gan, Bin Liu, Weijie Yuan, Ming Shi, Ai Peng, Lihua Wang, Xiaolan Chen, Tongqiang Liu, Shiying Zhang, Song Wang, Qing Gao, Baoxing Wang, Huixiao Zheng, Changhua Liu, Yuan Luo, Hong Ye, Hongli Lin, Yiwen Li, Qiang He, Feng Zheng, Ping Luo, Gang Long, Wei Lu, Kanghui Li, Junwei Yang, Yingxue Cathy Liu, Zhizheng Zhang, Xiaoling Li, Weifeng Zhang, Li Zuo, Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis, Nephrology Dialysis Transplantation, Volume 39, Issue 10, October 2024, Pages 1649–1661, https://doi.org/10.1093/ndt/gfae053
About Hyperphosphatemia
Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphorus level could cause multiple complications such as secondary hyperparathyroidism, renal osteodystrophy and vascular calcification. It is an independent risk factor of cardiovascular events and all-cause mortalities. A good control of serum phosphorus level could effectively improve the patients' outcome. For CKD patients undergoing dialysis treatment, the regular dialysis is not sufficient to remove the overload of serum phosphate in the body. Considering the limitations of low-phosphate diet which might cause dystrophia, oral use of phosphate binders is the prevailing treatment for hyperphosphatemia. However, there is low compliance for patients (less than 50% reaching good phosphate control) to use PBs due to gastrointestinal side effects, high pill burden etc.
According to Global and Chinese Hyperphosphatemia Drug Industry Blue Book by China Insights Consultancy in 2023, the out of target rate of serum phosphorus level in dialysis patients in Chinese mainland was significantly higher than other countries and regions. There is still room for improvement in terms of the proportion and duration of phosphorus binders usage. The market size of serum phosphorus lowering products in China is expected to reach 10 billion RMB by 2035.
About Alebund Pharmaceuticals
Alebund was incubated in Shanghai in 2018. It focuses on the discovery, development, production and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring greater therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal indications, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS) and autosomal dominant polycystic kidney disease (ADPKD). Alebund has completed the construction of its manufacturing site for small molecules in Yangzhou that will supply bulk of Alebund's pipeline drugs, including AP301, upon commercial launch. Alebund has also established a dedicated commercialization team in China, responsible for the commercial promotion of renal products.