FDA agrees to a single confirmatory phase III study of AR 301 and the clinical study design
Aridis Pharmaceuticals, Inc. announced positive feedback from the FDA on the Company’s proposed single confirmatory Phase III study of investigational monoclonal antibody candidate AR 301, which is being developed as an adjunctive therapy in combination with standard of care (SOC) antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients
Key agreements with FDA: i. FDA agreed on the design of the single confirmatory Phase III superiority study required to support the submission of a Biologics License Application (BLA). ii. FDA agreed to the proposed expansion of the confirmatory Phase III study in S. aureus ventilator associated pneumonia (VAP) patients to include ventilated hospital acquired pneumonia (HAP) and ventilated community acquired pneumonia (CAP) patients. iii. The clinical efficacy endpoint will be the same endpoint of Clinical Cure of pneumonia on Day 21 used in the previous Phase III superiority trial AR-301-002. However, the primary efficacy endpoint will be in older adults greater than 65 years of age - given that the absolute efficacy in the AR-301-002 Phase III study was higher in older adults than the overall population, i.e., +34% improvement on Day 21 (p= 0.057) and by +38% on Day 28 (p= 0.025) in older adults versus + 11% improvement (p=0.24) in the overall population. iv. The confirmatory AR-301-003 Phase III superiority study will be powered for efficacy in both the primary efficacy endpoint in adults greater than 65 years of age, and for the key secondary efficacy endpoint in all study subjects.
About the Confirmatory AR-301-00 3 Phase III Study: AR-301-003 will be the second and final of two planned superiority Phase III studies evaluating the efficacy and safety of AR 301 for adjunctive treatment of pneumonia caused by S. aureus in critically ill hospitalized patients. The study is a randomized, double-blind, superiority trial with the primary efficacy endpoint of Clinical Cure of pneumonia in adults 65+ years old at Day 21 post-treatment. The secondary endpoints will include Clinical Cure rates of pneumonia in study subjects greater than 65 and less than 65 years of age, safety including all-cause mortality, and healthcare utilization. Approximately 200 clinical sites in 20+ countries are expected to participate in the study, including US, Latin and S. America, Europe, and Asia Pacific.
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