AR-105: Broadly Active Human Monoclonal Antibody (mAb) Against Pseudomonas aeruginosa
The Gram negative bacterium Pseudomonas aeruginosa is one of the most important public health pathogens and is associated with a number of difficult-to-treat infections such as pneumonia, bacteremia, and cystic fibrosis lung infection. AR-105 (Aerucin®) is a broadly active, fully human IgG1 monoclonal antibody targeted against P. aeruginosa alginate, a widely distributed cell surface polysaccharide involved in surface adhesion, biofilm formation, and protection against the human immune system. Aerucin exhibits a broad recognition to diverse, unrelated P. aeruginosa clinical isolates due to the ubiquitous nature of the alginate surface polysaccharide. Aerucin’s mechanism of action is different from mechanisms of antibiotic resistance, and is effective against all P. aeruginosa clinical isolates tested.
Aerucin effectively protected against lethal challenges of a variety of P. aeruginosa strains in mouse models of acute pneumonia and bacteremia. This mAb candidate is being developed as first-line adjunctive therapy to standard of care antibiotics. Aerucin has successfully completed a Phase 1 clinical trial in 16 healthy volunteers, demonstrating safety up to doses of 20 mg/kg. A worldwide pivotal trial of Aerucin in ventilator associated bacterial pneumonia patients infected with P. aeruginosa was initiated in the second quarter of 2017 and is actively enrolling patients.