26 Mar Aridis Pharmaceuticals Commences Phase 1 Clinical Study of Aerucin™ Monoclonal Antibody for Acute Pneumonia
Study Expected to Complete in 4Q 2015
SAN JOSE, Calif., March 26th, 2015 – Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel immunotherapies for infectious diseases, announced today the initiation of a Phase 1 clinical study of Aerucin™, the Company’s broadly reactive, fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, which is being developed as an adjunctive treatment for acute pneumonia.
The Phase 1 clinical trial, expected to complete in the fourth quarter of 2015, is a single ascending dose safety and pharmacokinetics study in healthy volunteers. Advancing to this stage of development represents the culmination of longstanding collaborations with Harvard University and the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH). An Investigational New Drug (IND) application was recently filed with the U.S. Food and Drug Administration (FDA), which was approved in a timely fashion by the Agency.
Founder and Chief Executive Officer, Vu Truong, Ph.D., stated, “We are pleased to initiate an accelerated clinical development plan to generate proof-of-concept data that further characterize Aerucin’s bactericidal potency. We believe that directing the human immune response to fight life-threatening infections such as those associated with Gram-negative P. aeruginosa bacteria represents the future of new anti-infectives, and will be critical to solving the persistent problem of antibiotic resistance.”
Aerucin directly binds the polysaccharide alginate, widely expressed on the cell surface of P. aeruginosa, leading to complement deposition and improved immune recognition. Aerucin demonstrated phagocytic destruction of more than 90% of all Pseudomonas aeruginosa clinical isolates tested. Earlier preclinical studies of Aerucin support both therapeutic and prophylactic use of the monoclonal antibody.
About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® and pharmaceutical formulation technologies to produce novel infectious disease focused therapies. Aridis’ product pipeline includes AR-101 anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 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 and cystic fibrosis; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. Complementing the company’s portfolio of mAbs is PanaecinTM, a novel broad spectrum anti-infective with activities against bacteria, viruses, and fungi.
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, Panaecin™, Aerucin™, 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.
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D. (investors)
Amy Wheeler (media)