Aridis Pharma Says Phase 2a Study Of AR-501 In Cystic Fibrosis Meets Endpoints
(RTTNews) - Aridis Pharmaceuticals, Inc. (ARDS) announced Monday preliminary top-line results from the randomized, double blinded, placebo-controlled Phase 2a study of AR-501, which evaluated the safety and pharmacokinetics of three ascending doses of AR-501 administered as an inhaled aerosol in cystic fibrosis (CF) patients with confirmed Pseudomonas aeruginosa bacterial and other potential infections.
The study was conducted with funding support from the Cystic Fibrosis Foundation. AR-501 is being developed as a once-per-week inhaled dosing regimen that is self-administered using a commercially available nebulizer device.
The study's primary and secondary endpoints of safety and pharmacokinetics (PK) were met. Three weekly inhaled doses of AR-501 at 6.4mg, 20mg, and 40mg dose levels were also well tolerated in CF patients. Inhaled delivery achieved more than 10-fold higher respiratory uptake of gallium (AR-501) than past clinical studies of intravenous (IV) gallium.
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