Aridis: No statistical significance in primary endpoint in AR-301–002 study

Aridis Pharmaceuticals announced top-line results from the AR-301-002 Phase 3 study, which evaluated the superiority of adjunctive use of the investigational monoclonal antibody candidate AR-301 with standard of care, SOC, antibiotics versus SOC antibiotics alone, for the treatment of VAP caused by Gram-positive bacteria Staphylococcus aureus or S. aureus . AR-301-002, the first of two planned Phase 3 studies, enrolled 174 mechanically ventilated intensive care unit ICU patients who were likely to have pneumonia caused by S. aureus, with 120 of those patients ultimately meeting the criteria of S. aureus as the predominant cause of pneumonia being evaluated for efficacy. The COVID-19 pandemic and the subsequent conflict in Eastern Europe limited patient enrollment from the original target sample size of 240. "Despite the limitations of sample size and lack of statistical significance in the primary endpoint, we are pleased to see the clinical benefit trends across the study population." said Hasan Jafri, MD, Aridis’ Chief Medical Officer. "In particular, this study highlights the efficacy limitations of standard of care antibiotics and therefore the unmet medical needs in high-risk, vulnerable patient populations such as older adults and those infected with antibiotic resistant MRSA; populations where AR-301 has the potential to fulfill an unmet need," said Dr. Jafri.