According to the study data, the AB103 administered patients demonstrated a meaningful improvement across multiple endpoints compared to placebo.
The University of Washington Harborview Medical Center professor of surgery and chief of trauma, study PI Dr. Eileen Bulger said patients with necrotizing soft tissue infections have high rates of mortality, amputation, and large disfiguring wounds.
"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," Bulger added.
Quicker resolution of organ dysfunction, less time spent in ICU, minimum requirement of ventilator support and fewer surgical procedures were observed in AB103 administered patients besides rapid decline of systemic inflammatory biomarkers.
AB103 was well tolerated in the study with no considerable differences in adverse events rates between the groups.
Atox Bio CEO Dan Teleman said results demonstrate improvement across multiple end points with AB103, the first agent being specifically tested for NSTI.
"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," Teleman added.