The US FDA has accepted Aridis Pharmaceuticals’ Investigational New Drug (IND) application for AR-301, also referred to as Salvecin, the company’s fully human anti-Staphylococcal ?-toxin IgG1 monoclonal antibody being developed for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant ‘MRSA’ strains.
Acceptance of the IND application enables Aridis to expand and accelerate its current Phase 2a study of AR-301 as an adjunctive therapy with standard-of-care antibiotics into the United States.  The study is currently underway in three European countries, with further expansion into the United Kingdom also planned.  Top-line results from the accelerated Phase 2a study are expected in the first half of 2016.