Aridis Pharmaceuticals (NASDAQ:ARDS) received FDA orphan drug designation for AR-501 for the treatment of lung infections in patients with cystic fibrosis (CF).
AR-501 is an inhaled formulation of gallium citrate, a non-antibiotic, anti-infective agent being developed as a self-administered, weekly treatment. AR-501 demonstrated efficacy against antibiotic-resistant strains, and a low resistance profile in preclinical studies.
“This candidate diversifies our portfolio of novel non-antibiotic, anti-infective therapies and potentially provides a novel, convenient treatment option for CF patients to manage their chronic, life-long lung infections,” Vu Truong, Aridis’ CEO, said in a statement.
AR-501 is currently being evaluated in an ongoing Phase 1/2a clinical trial. Aridis expects to report data from the Phase 1 portion, which consists of healthy subjects, in the first quarter of 2020; and the Phase 2a portion, in CF patients, in the second quarter of 2021.
