Aridis Pharmaceuticals has announced that a Phase 2a study of the company’s AR-501 nebulized gallium in cystic fibrosis patients with P. aeruginosa lung infections met its primary and secondary endpoints, with all 3 dose levels tested being well tolerated. According to Aridis, uptake of AR-501 in the respiratory track was up to 10 times higher than previously reported levels for IV gallium that improved lung function and up to 50 times higher than the levels required to inhibit the bacteria. Development of AR-501 for the treatment of bacterial lung infections in CF patients is being supported by the Cystic Fibrosis Foundation.
In 2020, Aridis announced that the FDA had agreed to allow the company to skip a Phase 2 single ascending dose study and move directly into a multiple ascending dose study. The study enrolled 42 adult CF patients who received three weekly doses of AR-501 at either 6.4 mg, 20 mg, or 40 mg doses. Based on data from those dose cohorts, Aridis says, the company has received approval from the data and safety monitoring board and from the FDA to escalate the highest dose to 80 mg and expects to have data for that dose level in the second half of this year.
Aridis Chief Medical Officer Hasan Jafri said, “We are very pleased to see the safety and tolerability that we had observed in healthy volunteers also confirmed in CF patients. The high drug level achieved in the lungs along with low systemic exposure from inhaled delivery effectively overcome the limitations of conventional intravenous delivery, and provide a strong basis for a large efficacy study in CF and other lung infections.”
CEO Vu Truong commented, “Having met the primary and secondary endpoints of this study, we thank the Cystic Fibrosis Foundation for the tremendous support they’ve provided to help us complete this study. The attractive safety profile of AR-501, combined with the recent results from our AR-301 mAb Phase 3 program in older adults with ventilator associated pneumonia, provide Aridis with two promising first-in-class, novel anti-infectives. We look forward to discussing the results from these two programs with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to plan the definitive next study for each program to support the filing of a license application.”
Read the Aridis Pharmaceuticals press release.
