- Aridis Pharmaceuticals Inc ARDS announced preliminary topline results from the Phase 2a study of AR-501 in cystic fibrosis (CF) patients with confirmed Pseudomonas aeruginosa bacterial and other potential infections.
- The study evaluated the safety and pharmacokinetics of three ascending doses of AR-501 administered as an inhaled aerosol and was conducted with funding support from the Cystic Fibrosis Foundation.
- AR-501 is being developed as a once-per-week inhaled dosing regimen self-administered using a commercially available nebulizer device.
- Also Read: Aridis' Inhaled Pan-Coronavirus Antibody Cocktail Shows Encouraging Preclinical Action.
- The study's primary and secondary safety and pharmacokinetics (PK) endpoints were met.
- Three weekly inhaled doses of AR-501 at 6.4mg, 20mg, and 40mg dose levels were well tolerated. No drug-related serious adverse events (SAEs) were observed.
- The majority of treatment-emergent adverse events (TEAEs) were respiratory in nature and primarily mild to moderate in severity.
- CF patients achieved high uptake of AR-501 in the respiratory tract, as measured by sputum concentrations, at levels that were more than 50-fold higher than required for inhibition of the target bacteria P. aeruginosa
- Inhaled delivery achieved more than 10-fold higher respiratory uptake of gallium (AR-501) than past clinical studies of intravenous (IV) gallium, resulting in lung function improvement and P. aeruginosa reduction.
- Price Action: ARDS shares are up 47.70% at $0.68 during the premarket session on the last check Monday.
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