05 Jun Aridis Pharmaceuticals, Inc. Presents Positive Phase 2a Safety and Efficacy Data of Salvecin™ (AR-301) in Patients with Severe Pneumonia Caused by Staphylococcus aureus During the 2017 ASM Microbe Congress
SAN JOSE, Calif. – June 05, 2017 – 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.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of AR-101, AR-301, Aerucin®, Panaecin™, AR-401, AR-201, Aridis’ proprietary formulation and delivery technologies, about Aridis’ strategy, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Aridis’ expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Aridis’ research and clinical studies and its ability to obtain additional financing. These forward-looking statements represent Aridis’ judgment as of the date of this release. Aridis disclaims any intent or obligation to update these forward-looking statements.
Andrew Mielach (media)