Biopharmaceutical company Aridis Pharmaceuticals Inc (Nasdaq:ARDS) reported on Wednesday that it has received the US Food and Drug Administration's (FDA) orphan drug designation (ODD) for the evaluation and development of AR-501 for treatment of lung infection in patients with cystic fibrosis.

Cystic fibrosis patients often suffer from severe, persistent secondary bacterial lung infections due to their underlying lung disease which results in an immune-compromised state.

AR-501, the company's inhaled formulation of gallium citrate, is a non-antibiotic, small molecule anti-infective and the gallium functions as an iron analogue that antagonises multiple iron-dependent pathways in microbes and thus, subverts multiple key functions in bacteria.

Under an ongoing Phase 1/2a clinical trial, which is funded by the Cystic Fibrosis Foundation, AR-501 is being developed as a self-administered, weekly treatment for cystic fibrosis. The company expects to report data from the Phase 1 portion in healthy subjects in Q1 2020 and the Phase 2a segment in cystic fibrosis subjects in Q2 2021.