Aridis says AR-105 Phase 2 clinical trial did not meet primary endpoint
Aridis Pharmaceuticals announced results from the company's first-in-patient Phase 2 clinical trial evaluating AR-105, a fully human IgG1 monoclonal antibody for the treatment of ventilator-associated pneumonia, or VAP, caused by gram-negative Pseudomonas aeruginosa. The recently completed study did not meet its primary endpoint of demonstrating superiority in Clinical Cure rates on Day 21 compared to placebo. Furthermore, there was a statistically significant imbalance in all-cause mortality, as well as Serious Adverse Event, or SAE, rates between treatment groups that favored placebo. However, no SAE or mortality in the study was deemed to be drug related by the study investigators or the study's Data Monitoring Committee. At this point, the company will no longer allocate further development resources to AR-105.