Inhaled Gallium Citrate Gets Orphan Drug Designation for Lung Infection Tx in Cystic Fibrosis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to AR-501 (gallium citrate; Aridis Pharmaceuticals, Inc), an investigational treatment for chronic bacterial lung infections in patients with cystic fibrosis (CF).

AR-501, an inhaled formulation of gallium citrate, is a small molecule anti-infective with broad spectrum activity against Gram-negative and Gram-positive bacteria in vitro, including antibiotic-resistant strains. Gallium works as an iron analogue and is believed to inhibit iron-dependent synthetic and metabolic pathways required for disease progression. The inhaled formulation is being developed as a self-administered weekly treatment. 

The Company is currently investigating AR-501 in a  phase 1/2a clinical trial funded by the Cystic Fibrosis Foundation. Phase 1 trial data is expected to be reported in the first quarter of 2020 and phase 2a data is expected in the second quarter of 2021.

For more information visit aridispharma.com.