Aridis Pharmaceuticals closes patient enrollment in Phase 2a study of AR-501

Aridis Pharmaceuticals announced the closing of patient enrollment in the multiple ascending dose and dose-ranging cohorts in the Phase 2a clinical trial of AR-501 in cystic fibrosis patients. The Company is on track to complete database lock, data analyses, and disclose top-line data in the first quarter of 2023. The Phase 2a study enrolled 39 CF patients from 24 clinical centers in the US. The CF patients were randomized and treated in 4 cohorts; 3 cohorts received three weekly multiple ascending doses of active drug at 6.4 mg, 20 mg and 40 mg or placebo, while the 4th Cohort being dose-ranging with subjects randomized to three weekly doses of AR-501 6.4 mg, 20 mg, or 40 mg, or placebo. CF subjects were followed for 28 days after last study dose for safety and pharmacokinetics of inhaled AR-501. Aridis previously reported positive Phase 1 safety data in June 2020 in healthy adults who were exposed to either a single ascending dose regimen or a multiple ascending dose regimen. "We worked diligently through the pandemic to enroll patients and are very pleased to reach this key milestone for our Phase 2a study of AR-501 in CF patients." commented Aridis’ Chief Medical Officer Hasan Jafri, MD. "Our focus is now on data gathering from the clinical trial centers. We anticipate reporting top-line results in the first quarter of 2023."