AtoxBio has announced top line results from a Phase IIa clinical trial of AB103 for the treatment of necrotizing soft tissue infections (NSTI), a life-threatening bacterial infection with significant morbidity and high mortality rate. The trial, at six US medical centers, found that patients treated with the drug had a meaningful improvement and suffered no side effects.
“We are very encouraged to see such promising results demonstrating improvement across multiple end points with AB103, the first agent being specifically tested for NSTI, a life-threatening and debilitating disease,” said Dan Teleman Atox Bio’s CEO. “There are currently no approved treatments specifically for NSTI. Given these clinical trial results and AB103’s FDA Fast-Track and Orphan Drug status, we hope to accelerate the development of AB103 and make it available to NSTI patients.”
The study included 40 participants — AB103 was administered to 30 patients while 10 patients received placebo. All patients also received standard of care treatment for NSTI including surgical removal of necrotic tissue, antibiotics and supportive care.
AtoxBio’s drug, AB103, is a rationally designed, short peptide that modulates the host’s inflammatory response and improves the body’s ability to effectively fight the flesh-eating bacteria.
“Patients with necrotizing soft tissue infections are critically ill with high rates of mortality, amputation, and large disfiguring wounds. There are few treatment options for this devastating disease. These early results utilizing AB103 suggest a promising new therapy for this disease. We look forward to continuing with a larger clinical trial to establish the optimal treatment regimen,“ said Dr. Eileen Bulger, Professor of Surgery and Chief of Trauma at the University of Washington Harborview Medical Center.
“These are devastating infections that need immediate and often repeated surgical intervention, and prolonged courses of antibiotics. A new and safe treatment to reduce the need for repeated surgeries, and long ICU stays would be a welcome addition to current NSTI management strategies,” said Dr. Steven Opal, Brown Medical School professor of medicine, who also serves as Memorial Hospital of Rhode Island’s chief of its infectious disease division and a member of Atox Bio’s Scientific Advisory Board.