Aridis Receives Agreement from the FDA on a Single Confirmatory Phase 3 Study of AR-301 and the Clinical Study Design

LOS GATOS, Calif., May 31, 2023 (GLOBE NEWSWIRE) -- 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)

“We are particularly gratified to reach concurrence with the FDA on the overall study design, endpoints, and patient populations,” said Aridis CEO Vu Truong. “This provides a clear clinical and regulatory pathway to bring AR-301 to patients with high unmet medical needs and enhances the opportunity for potential pharma partners.”

About the Confirmatory AR-301-003 Phase 3 Study

AR-301-003 will be the second and final of two planned superiority Phase 3 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 ≥65 and <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.