Why Are Aridis Pharmaceuticals Shares Moving Higher Today?

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.

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article Why Are Aridis Pharmaceuticals Shares Moving Higher Today? originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.