02 Aug Aridis Pharmaceuticals Enrolls First Patients in Global Pivotal Clinical Trial of Novel Monoclonal Antibody for Treating Acute Pneumonia
SAN JOSE, Calif. – August 2, 2017 – Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, today announced that it is now actively enrolling patients in a global pivotal study of Aerucin®, the Company’s broadly reactive monoclonal antibody being developed to treat acute pneumonia caused by Gram-negative bacteria Pseudomonas aeruginosa. The randomized, double-blinded, placebo-controlled trial is ongoing in 14 countries worldwide.
“We are excited to advance the development of Aerucin into a pivotal clinical trial,” stated Vu Truong, Ph.D., Founder and CEO of Aridis. “This study evaluates the potential therapeutic benefits of our anti-P. aeruginosa antibody Aerucin® as an adjunctive therapy in combination with antibiotics in critically ill pneumonia patients. Propelled by positive safety data in humans and preclinical evidence that Aerucin is effective against a broad range of P. aeruginosa clinical isolates – including antibiotic-resistant strains – we look forward to evaluating its ability to improve clinical outcomes compared to standard of care antibiotics alone in a diverse, global patient population. We expect to complete the study in the second half of 2018.”
Aerucin is a fully human monoclonal IgG1 antibody that binds to alginate, a cell surface polysaccharide that is widely distributed on P. aeruginosa. Once bound, Aerucin improves recognition and destruction by the immune system through enhanced complement deposition. Aerucin has proven effective in promoting phagocytic killing of a wide range of both mucoid and non-mucoid P. aeruginosa clinical isolates, including antibiotic-resistant strains from pneumonia and cystic fibrosis patients. In an animal model of acute pneumonia, Aerucin protected mice from lethal P. aeruginosa challenges at doses as low as 0.004 mg/kg. It also protected animals against eye infections in a keratitis model and sepsis in a systemic infection model. These studies support both therapeutic and prophylactic uses of Aerucin against a broad range of P. aeruginosa 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 (or ‘AerumabTM’) 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 (Salvecin®), 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.