Aridis Meets Primary and Secondary Endpoints in Cystic Fibrosis Clinical Trial

Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) has met the primary and secondary endpoints in safety and pharmacokinetics in a Phase 2a clinical trial evaluating a treatment in cystic fibrosis (CF).

Aridis’ lead candidate, AR-501, has received Orphan Drug, Fast Track and Qualified Infectious Diseases Product designations in the United States, and Orphan Drug designation in Europe, as a potential treatment of CF-related lung infections.

Highlights

• The study evaluated the safety and pharmacokinetics of three ascending doses of AR-501 administered as an inhaled aerosol in CF patients with Pseudomonas aeruginosa bacterial infections.
• CF patients achieved high uptake of AR-501 in the respiratory tract, at levels that were more than 50-fold higher than required for inhibition of the target bacteria.
• Inhaled delivery achieved more than 10-fold higher respiratory uptake of AR-501 than past clinical studies of intravenous (IV) AR-501, which resulted in lung function improvement and bacteria reduction.
• AR-501 is being developed as a once-weekly inhaled medication that will be self-administered using a commercially available nebulizer device.

The study was conducted with funding support from the Cystic Fibrosis Foundation.