Australian biotechnology company Arana Therapeutics says its lead anti-inflammatory compound ART621 has successfully passed review of its rheumatoid arthritis Investigational New Drug (IND) application by the Food and Drug Administration (FDA).
IND status indicates regulatory approval to conduct clinical trials in humans in the United States and represents the first review of ART621 data by a major Regulatory Authority. Arana said it will now proceed with its planned phase II study in rheumatoid arthritis.
Dr John Chiplin, Arana CEO said, “We are delighted with this positive result which validates Arana’s technology and development expertise. Crucially, an open IND increases our commercial visibility and is an important catalyst for our ongoing partnering discussions.”