05 Jan Aridis Pharmaceuticals Reports Positive Clinical Data from Phase 1/2a Study of Human Monoclonal Antibody AR-301 for Treating Pneumonia
SAN JOSE, Calif. – January 5, 2017 – Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, today announced positive clinical results from its Phase 1/2a study of AR-301, its fully human monoclonal antibody against Staphylococcus aureus alpha-toxin being evaluated as an adjunctive therapy in combination with standard of care antibiotics for hospital-acquired pneumonia and ventilator-associated pneumonia (“HAP” and “VAP”). The double-blind, placebo-controlled study met its primary endpoint of safety. Aridis will move forward with plans for late-stage clinical studies of AR-301 in 2017.
“These clinical results for AR-301 are very encouraging,” stated Paul-Andre de Lame, M.D., Aridis’ Chief Medical Officer. “As anticipated, our antibody was safe and well tolerated by HAP and VAP patients at all dose levels. Exploratory analyses of efficacy are currently ongoing.”
Vu Truong, Ph.D., Chief Executive Officer of Aridis, further added, “We look forward to discussing the full results with the FDA in the coming months and to advancing AR-301 toward late-stage clinical studies.”
AR-301 (or Salvecin™) is a fully human monoclonal IgG1 antibody that specifically targets S. aureus alpha-toxin and protects host cells from destruction. It was discovered by applying Aridis’ MabIgX® technology to screen human B-cells of convalescent pneumonia patients. S. aureus is a gram-positive bacterium and is among the leading causative agents of bacterial pneumonia in intensive care units (ICU) and other hospital-acquired infections. S. aureus is also a common pathogen in other infections including the skin and soft tissues infection, post-surgery infection, endocarditis, bacteremia, sepsis, and toxic shock syndrome. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus, hence it is active against drug-resistant strains, including MRSA (methicillin-resistant S. aureus). In animal studies, AR-301 reduced bacterial load and significantly improved survival following localized and systemic S. aureus infections.
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 (‘Aerumab™’) anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (‘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)