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Alebund’s Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SHANGHAI, March 29, 2024 /PRNewswire/ — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

“We are very excited that AP303 has been granted Orphan Drug Designation by the FDA”, Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.”

AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model. AP303 has completed its first-in-human study in healthy subjects in Australia and is ready for a Phase II trial in ADPKD. The prevalence of ADPKD is reported to be between 1 in 400 and 1 in 1,000 live births; it is an important cause of end-stage kidney disease (ESKD) requiring renal replacement therapy [1]. This Orphan Drug Designation reflects the need for more new treatment options and the potential for AP303 to address the pressing needs of people living with ADPKD.

The US FDA’s ODD is a special status granted to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. The designation provides incentives to advance the development of treatments for rare diseases, including marketing exclusivity, tax credits for clinical research costs, and exemption from prescription drug user fees.

About ADPKD

ADPKD is the most common monogenic kidney disease and one of the leading causes of end-stage kidney disease in adults worldwide. Its course is characterized by the development and inexorable expansion of multiple cysts scattered throughout the kidney parenchyma. ADPKD is most caused by mutations in the genes PKD1 (in 78% of disease pedigrees) or PKD2 (in 15% of disease pedigrees). Treatment recommendation for patients with ADPKD includes anti-hypertensive treatment, dietary restrictions, and pharmacotherapy for a limited percentage of suitable patients. More broadly applicable treatment options with fewer side effects are needed to effectively slow the decline of kidney function and improve kidney outcomes in patients with ADPKD.

About Alebund Pharmaceuticals

Alebund is a biopharmaceutical company jointly incubated by a group of industry leaders in the field of nephrology in Shanghai in 2018. 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). Alebund’s pipeline comprises both small-molecule and biological assets, in which many programs are in the clinical stage.

[1] Bergmann, C., Guay-Woodford, L.M., Harris, P.C. et al. Polycystic kidney disease. Nat Rev Dis Primers 4, 50 (2018). https://doi.org/10.1038/s41572-018-0047-y

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