Alebund Pharmaceuticals has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its investigational drug AP303.
This designation is intended for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes the growth of numerous cysts in the kidneys.
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AP303 is an internally developed drug candidate that has shown promise in improving renal survival in an ADPKD mice model.
The drug has successfully completed a first-in-human study in healthy subjects in Australia and is poised to enter Phase II trials.
ADPKD has a prevalence of between one in 400 and one in 1,000 live births and is a significant cause of end-stage kidney disease (ESKD), which often necessitates renal replacement therapy.
Alebund co-founder, chairman, and CEO Dr Gavin Xia said: “We are very excited that AP303 has been granted orphan drug designation by the FDA.
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By GlobalData“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.”
The FDA’s ODD supports the development of drugs for rare diseases or disorders that affect fewer than 200,000 US people.
This status comes with several benefits, including marketing exclusivity upon approval, tax credits for clinical testing, and exemption from certain FDA fees, which can accelerate the drug’s development and review process.
Biopharmaceutical company, Alebund is engaged in the discovery and development of new therapies primarily for kidney diseases and their complications, as well as other chronic conditions.
