Aridis Pharmaceuticals Inc (NASDAQ:ARDS) shares are gaining after announcing positive European Medicines Agency feedback on its proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301.
AR-301 is being developed as an adjunctive therapy with standard-of-care (SOC) antibiotics for 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 FDA, which include:
- Agreement on the design of the single confirmatory Phase 3 superiority study required to support the submission of a marketing application with the primary efficacy endpoint in older adults.
- 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 and ventilated community-acquired pneumonia 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’.
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.
Approximately 200 clinical sites in 20+ countries are expected to participate in the study.
Price Action: ARDS shares are up 29.40% at $0.34 during the premarket session on the last check Tuesday.
