Atox Bio has announced positive top-line data from a Phase IIa trial of AB103 in patients with necrotising soft tissue infections (NSTI).
Data revealed that the patients administered with AB103 had a meaningful improvement across multiple endpoints compared to placebo.
The University of Washington Harborview Medical Center professor of surgery, chief of trauma and study principal investigator Dr Eileen Bulger said patients with necrotising soft tissue infections have high rates of mortality and amputation, and large disfiguring wounds.
"These early results utilising 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 said.
AB103-administered patients experienced faster resolution of organ dysfunction, spent fewer days in ICU, did not require ventilation support for many days and needed fewer surgical procedures for infected tissue removal than patients treated with the placebo.
Faster decline of systemic inflammatory biomarkers was also observed.
AB103 was well-tolerated in the study with no considerable differences in rates of adverse events between the groups.
Atox Bio CEO Dan Teleman said results demonstrate improvement across multiple endpoints 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 said.
AB103 is a short peptide designed to transform the host's inflammatory response and improve the body's ability to combat the infection.