Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company’s AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had also recently granted orphan drug designation to AR-501, also known as “Panaecin,” for that indication.
A Phase 1/2a study of AR-501 is underway in healthy volunteers and in CF patients with chronic P. aeruginosa lung infections. According to the company, preclinical studies have shown that AR-501, which serves as an iron analog to inhibit bacterial pathogenesis. “works synergistically with multiple antibiotics, is effective against antibiotic resistant strains, and has a low intrinsic resistance profile.” The inhaled formulation is designed for once a week dosing.
Aridis CEO Vu Truong said, “Receiving orphan designation from the EMA for AR-501 is an important step in ensuring the program is well positioned from a global regulatory development pathway standpoint as we continue to advance its ongoing Phase 1/2a clinical trial. We remain on track to report data from the Phase 1 segment of the trial consisting of healthy subjects in Q1 2020 and the Phase 2a portion with cystic fibrosis subjects in Q2 2021.”
Read the Aridis Pharmaceuticals press release.
