Aridis Pharmaceuticals (ARDS)

Aridis Pharmaceuticals (ARDS) is a late-stage biopharmaceutical company focused on the discovery and development of targeted immunotherapy using fully human monoclonal antibodies (mAbs), to treat life-threatening infections. mAbs represent a fundamentally new treatment approach in the infectious disease market and are designed to overcome key issues associated with current therapies, including drug resistance, short duration of response, negative impact on the human microbiome, and lack of differentiation in treatment options. Their proprietary product pipeline primarily targets hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP). Three of their product candidates have exhibited promising preclinical and clinical data available from two completed studies and are in pivotal trial stage. Their lead product candidate, AR-301 (Salvecin), targets the alpha toxin produced by gram (+) bacteria Staphylococcus aureus (S. aureus), a common pathogen associated with HAP and VAP. ARDS has conducted an end-of-Phase 2 meeting with the FDA, and expects to initiate a Phase 3 trial for AR-301 in 2H18. Additionally, they are developing AR-105 (Aerucin), and AR-101 (Aerumab). AR-105 targets gram (-) bacteria Pseudomonas aeruginosa (P. aeruginosa) and has been granted Fast-Track Designation (FTD) by the FDA. They initiated a global Phase 2 trial for AR-105 in HAP and VAP patients in 2Q17 and expect data in 2H19. AR-101 also targets gram (-) bacteria P. aeruginosa and has been granted orphan drug designation (ODD) in the US and EU. They plan to initiate a Phase 2/3 pivotal trial for AR-101 in the 2H19.