Aridis Pharmaceuticals presented top-line results of its Phase 2a trial of Salvecin (AR-301), its human monoclonal antibody used as an adjunct therapy for severe pneumonia caused by Staphylococcus aureus, at the ASM Microbe Congress.
This study was a randomized, double-blind, placebo-controlled, first-in-human trial designed to assess the safety, pharmacokinetic characteristics, and efficacy of ascending doses of Salvecin as an adjunct therapy for severe pneumonia caused by S. aureus. In total, 48 patients were enrolled among 13 intensive care units (ICUs) in Belgium, France, Spain, the United Kingdom, and the United States.
Patients in this study were diagnosed with severe hospital-acquired pneumonia (HABP) caused by S. aureus, the majority being mechanically ventilated. They were assigned at random to standard-of-care antibiotics plus either Salvecin or placebo. Patients who received Salvecin experienced no related serious adverse events at any dose level tested, and no difference in adverse effects was observed among the groups. Ventilator-associated bacterial pneumonia (VABP) patients treated with antibiotics plus Salvecin at all dose levels spent a shorter time under mechanical ventilation as compared to antibiotics plus placebo. Eradication of S. aureus was also consistently higher in the group receiving Salvecin at all dose levels.
"Hospital-acquired bacterial pneumonia (HABP) due to S. aureus affects more than 500,000 patients a year in the U.S., Europe, and Japan," Vu Truong, Ph.D., Chief Executive Officer of Aridis said. "In addition to finding Salvecin safe and tolerable, encouraging efficacy indicators were observed. We believe our approach will help significantly improve the clinical course of patients with HABP. Advancing this new, antibody-based immunotherapy towards late-stage clinical studies in the coming months is a priority for Aridis, especially in these times of emerging multi-drug resistant S. aureus. This innovative and potentially break-through treatment may represent a much-needed therapeutic advance for patients hospitalized in an ICU with S. aureus pneumonia."