Atox Bio announced new data in an animal model of necrotizing soft tissue infection (NSTI), commonly known as “flesh eating bacteria” demonstrating that administration of a single dose of AB103, given several hours after infection even without any antibiotics, increased survival in animals, and reduced tissue necrosis, inflammation and bacterial burden at the site of infection without compromising
the immune response. NSTI or flesh eating bacteria is a life-threatening bacterial infection with significant morbidity and no currently approved therapies.
These finding are significant as they suggest that AB103 has a broad therapeutic window and could be used even in cases of antibiotic ineffectiveness such as with antibiotic resistant bacteria. The data were published in a paper titled “A peptide antagonist of CD28 signaling attenuates toxic shock and necrotizing soft tissue infection induced by Streptococcus pyogenes” that was published in the March issue of the Journal of Infectious Diseases.
This new research supports the positive results obtained in the recently completed Phase 2a clinical trial with AB103 in 40 patients with NSTI conducted at 6 leading medical centers across the U.S. The randomized, double-blind, placebo-controlled study demonstrated that patients treated with AB103 had a meaningful improvement across multiple endpoints in NSTI caused by different types of pathogens, including gram positive bacteria, gram negative bacteria and mixed infections. Patients treated with AB103 had a faster resolution of organ dysfunction, spent fewer days in the intensive care unit, required fewer days
AB103 has received orphan drug status from the FDA in October 2011 and fast track status in August 2012.