SAN JOSE, CA, USA I June 05, 2017 I Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, 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 held, June 1 – 5, 2017, in New Orleans.
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™ (AR-301) 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,” stated Vu Truong, Ph.D., Chief Executive Officer of Aridis. “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.”
About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies. Aridis’ product pipeline includes AR-101 (or ‘Aerumab™‘) anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (or ‘Salvecin™‘) anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin®, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia; Panaecin™, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody.
SOURCE: Aridis Pharmaceuticals
Post Views: 15
SAN JOSE, CA, USA I June 05, 2017 I Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, 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 held, June 1 – 5, 2017, in New Orleans.
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™ (AR-301) 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,” stated Vu Truong, Ph.D., Chief Executive Officer of Aridis. “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.”
About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies. Aridis’ product pipeline includes AR-101 (or ‘Aerumab™‘) anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (or ‘Salvecin™‘) anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin®, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia; Panaecin™, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody.
SOURCE: Aridis Pharmaceuticals
Post Views: 15
