Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301

LOS GATOS, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the European Medicines Agency (EMA) 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 by the EMA were similar to those agreed by the US FDA, which include:

• Agreement on the design of the single confirmatory Phase 3 superiority study required to support the submission of a Marketing Authorization Application (MAA) with the primary efficacy endpoint in older adults (≥65 yrs).
  • In the first Phase 3 study ‘AR-301-002’, the magnitude of absolute efficacy was higher in older adults, 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.
• Agreement to the proposed expansion of the confirmatory Phase 3 study in S. aureus ventilator associated pneumonia (VAP) patients to include S. aureus pneumonia in ventilated hospital acquired pneumonia (HAP) and ventilated community acquired pneumonia (CAP) patients.
• Agreement on Clinical Cure of pneumonia on Day 21 as the primary efficacy endpoint, as in the first Phase 3 study ‘AR-301-002’.

“We are particularly gratified to reach concurrence, first with the FDA, and now with the EMA on the overall study design, endpoints, and patient populations,” said Aridis CEO Vu Truong. “This provides for a globally harmonized clinical study and regulatory pathway to bring AR-301 to patients with high vulnerabilities to Staph. Aureus infections, particularly older adults whose immune system is in the inevitable steady decline as they age.”

About the Confirmatory AR-301-003 Phase 3 Study
AR-301-003 will be the second and final of two planned Phase 3 superiority studies evaluating the efficacy and safety of AR-301 for adjunctive therapy 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.