Aridis: FDA OK on Single Confirmatory Phase 3 Study of AR-301

 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the FDA on the Company’s proposed single confirmatory Phase 3 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:

• FDA agreed on the design of the single confirmatory Phase 3 superiority study required to support the submission of a Biologics License Application (BLA).

• FDA agreed to the proposed expansion of the confirmatory Phase 3 study in S. aureus ventilator associated pneumonia (VAP) patients to include ventilated hospital acquired pneumonia (HAP) and ventilated community acquired pneumonia (CAP) patients.

• The clinical efficacy endpoint will be the same endpoint of Clinical Cure of pneumonia on Day 21 used in the previous Phase 3 superiority trial AR-301-002. However, the primary efficacy endpoint will be in older adults ≥65 years of age - given that the absolute efficacy in the AR-301-002 Phase 3 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.

• The confirmatory AR-301-003 Phase 3 superiority study will be powered for efficacy in both the primary efficacy endpoint in adults ≥65 years of age, and for the key secondary efficacy endpoint in all study subjects (≥65 and <65 years of age)

https://finance.yahoo.com/news/aridis-receives-agreement-fda-single-120000132.html