The pneumonia treatment AR-301 (Salvecin) has proven safe in Phases 1 and 2 of clinical trials, its maker, Aridis Pharmaceuticals, has announced.
The compound, which targets the Staphylococcus aureus alpha-toxin, is designed to be used in combination with antibiotics that treat hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).
The next phase of the double-blind, placebo-controlled trial (NCT01589185) will be late-stage clinical studies in 2017 aimed at assessing AR-301’s effectiveness.
The S. aureus alpha-toxin protein destroys human cells, including the critical immune cells that fight invading pathogens.
AR-301 is a human monoclonal antibody that targets the alpha-toxin. Aridis researchers discovered it while using the company’s MabIgX technology to check the B-cells of recovering pneumonia patients.
Animal studies have shown that AR-301 reduces S. aureus bacteria and improves survival rates.
S. aureus often causes pneumonia in intensive care units and other hospital settings. It is also a common pathogen in tissue, post-surgery and other infections.
Multi-drug-resistant strains of bacteria, such as methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA), have made treatment of infections more challenging. This is particularly true in hospitals and other healthcare settings.
AR-301 works against normal as well as drug-resistant strains of S. aureus.
“These clinical results for AR-301 are very encouraging,” Paul-Andre de Lame, MD, Aridis’ chief medical officer, said in a press release. “As anticipated, our antibody was safe and well tolerated by HAP and VAP patients at all dose levels. Exploratory analyses of efficacy are currently ongoing.”
“We look forward to discussing the full results with the FDA [U.S. Food and Drug Administration] in the coming months and to advancing AR-301 toward late-stage clinical studies,” added Vu Truong, PhD, Aridis’ chief executive officer.
