AP303 Receives FDA Orphan Drug Designation for Treatment of ADPKD

The US Food and Drug Administration (FDA) granted orphan drug designation to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

AP303 was developed by Alebund Pharmaceuticals, a biopharmaceutical company focused on innovative therapies for the treatment of renal diseases. The drug completed its first in-human study in healthy subjects in Australia, and a phase 2 trial in ADPKD is imminent.

“We are excited that AP303 has been granted orphan drug designation,” said Gavin Xia, PhD, cofounder, chair, and chief executive officer of Alebund. “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 designation means that Alebund will qualify for incentives, such as marketing exclusivity, clinical research tax credits, and exemption from prescription drug user fees.