Clinical-stage biopharmaceutical company Kind Pharmaceutical (Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC) announced on Friday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) Office of Orphan Products Development for its AND017 intended for the treatment of Sickle Cell Disease (SCD).
AND017 is being developed to treat various anaemia indications associated with diseases including non-dialysis dependent chronic kidney disease (NDD-CKD) and dialysis-dependent chronic kidney disease (DD-CKD).
The results for AND017's phase 1 in healthy subjects and phase 2 clinical trials in treatment of anaemia in NDD-CKD and anaemia in DD-CKD were presented at last week's annual meeting of American Society of Nephrology (ASN) Kidney Week in San Diego. The preclinical work supporting AND017's ODD in SCD will be presented in future scientific meeting and subsequently published in a scientific journal.
Dong Liu, PhD, Kind Pharmaceutical founder, chairman, and CEO, said, 'The FDA's granting of ODD for AND017 underscores the urgent medical need for new therapies, particularly oral drugs to safely and effectively treat patients with SCD. The granting of ODD also demonstrates the innovation capability and the vision of Kind Pharmaceutical.'
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