March 17, 2023, Shanghai, China—Alebund Pharmaceuticals (“Alebund” or the “Company”) announced that China’s National Medical Products Administration (NMPA) has granted approval for the company’s IND application for a phase 3 study of AP301 to treat hyperphosphatemia in dialysis patients.
IND approval information for AP301 capsule
AP301, a new-generation iron-based phosphate binder, is a class Ⅰ drug developed by Alebund for the treatment of hyperphosphatemia in patients with renal failure. Through binding to phosphate in the gastrointestinal (GI) tract and reducing GI phosphate absorption, AP301 decreases serum phosphorus levels and improves the long-term outcome of patients with renal failure. This is a phase 3, randomized, open-label, multicenter study to evaluate the efficacy and safety of AP301 on serum phosphorus control in chronic kidney disease patients receiving maintenance dialysis with hyperphosphatemia. In the previously completed phase 1 and phase 2 studies, AP301 showed an efficacious effect on lowering serum phosphorus in the same population and was safe and well tolerated.
“More than eight hundred thousand patients are receiving dialysis in China, and the number continues to grow rapidly. Less than half of them whose serum phosphorus levels are under control, there is a pressing unmet medical need.” said Dr. Jin Tian, CMO of Alebund, “We hope that the phase 3 study will progress smoothly, and we can soon provide a safe and efficacious treatment option to the patients.”
“With the company’s most clinically advanced products entering the late-stage clinical development, Alebund has been actively preparing on the manufacturing end. Our research and production facility in Yangzhou, China, would lay a strong milestone on our path to launch and commercialize Alebund’s pipelines in China and overseas.” Gavin Xia, CEO of Alebund said, “The recent advancements in our pipelines and the construction of the Yangzhou facility demonstrate Alebund’s dedication and commitment to the renal disease area.”
Bird-view picture of the Yangzhou Facility under construction (picture taken on March 13, 2023)
Hyperphosphatemia is one of the most common complications in patients with chronic kidney disease. Chronically high blood phosphorus levels can cause multiple complications e.g., secondary hyperparathyroidism, renal osteodystrophy, and vascular calcification. It is an independent risk factor of cardiovascular risk and all-cause mortalities. Controlling serum phosphorus can effectively improve the patient’s outcome with chronic kidney disease.
About Alebund Pharmaceuticals
Alebund is a startup jointly incubated by a group of industry leaders in the field of nephrology in Shanghai in 2018. As a clinical-stage biopharmaceutical company, Alebund focuses on the discovery and development of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal diseases, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, and autosomal dominant polycystic kidney disease (ADPKD). Alehund’s pipeline comprises both small-molecule and biological assets.