Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) receives encouraging input from the FDA for the proposed confirmatory Phase 3 trial of AR-301, an investigational monoclonal antibody. The treatment, in tandem with standard of care antibiotics, targets pneumonia instigated by Gram-positive bacteria, Staphylococcus aureus (S. aureus), in mechanically ventilated hospital patients.
Key Approvals from FDA
FDA Backs Phase 3 Study Design and License Application
The FDA supports the design of the pivotal confirmatory Phase 3 study, a crucial stepping stone towards the submission of a Biologics License Application (BLA).
FDA Approves Study Expansion for Pneumonia Patients
The FDA also concurs with extending the Phase 3 study to include ventilator-associated pneumonia (VAP), hospital-acquired pneumonia (HAP), and community-acquired pneumonia (CAP) patients with S. aureus.
Primary Efficacy Endpoint for Elderly Patients
Efficacy Endpoint for AR-301-003 Phase 3 Superiority Study
The clinical efficacy endpoint will remain the same as in the previous trial, AR-301-002. However, the primary efficacy endpoint will target older adults aged ≥65 years, given the significantly higher efficacy results observed in this demographic.
Confirmatory AR-301-003 Phase 3 Superiority Study Highlights
The AR-301-003 Phase 3 superiority study will assess efficacy in the primary endpoint (adults ≥65 years of age) and a key secondary endpoint (all study subjects of ages ≥65 and <65).
Aridis Pharmaceuticals CEO Commends FDA’s Approval
Aridis CEO, Vu Truong, expresses satisfaction over the FDA’s consensus on the study design, endpoints, and patient populations. The approval provides a solid clinical and regulatory path for AR-301, targeting patients with high unmet medical needs.
“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.”
Details of the Confirmatory AR-301-003 Phase 3 Study
AR-301-003 Phase 3 Study Overview
The AR-301-003 Phase 3 study will be the final one in two planned superiority trials assessing the safety and efficacy of AR-301 as an adjunctive treatment for pneumonia caused by S. aureus. It will be a randomized, double-blind superiority trial with multiple efficacy endpoints and will encompass approximately 200 clinical sites in over 20 countries.
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