Israeli biotechnology firm Atox Bio has started patient enrolment in its Phase III trial (ACCUTE) to evaluate AB103, the first candidate developed to treat necrotising soft tissue infections (NSTIs), also called flesh eating bacteria.
NSTIs are caused by a range of bacteria, including streptococcus and staphylococcus. These enter the body through minor cuts, surgery, insect bits or other methods, and spread to the connective tissue layer below the skin.
NSTIs cause significant tissue damage and can quickly become systemic, leading to multiple organ dysfunction.
Around 290 patients will be enrolled in the Phase III AB103 clinical composite endpoint study in necrotising soft tissue infections (ACCUTE) trial, which is being carried out at about 40 centres in the US.
Patients will receive AB103 or placebo, administered as a single dose during or shortly after initial surgical debridement, in addition to standard-of-care treatment.
The trial’s primary endpoint is a clinical composite based on local and systemic components of this disease.
Secondary endpoints include time to resolution of organ dysfunction, recovery from acute kidney injury, and economic outcomes such as days on ventilation, days in the ICU, and duration of hospital stay.
Atox Bio CEO Dan Teleman said: "We are looking forward to working with the high-quality clinical sites in the ACCUTE study to evaluate AB103 in rapidly advancing NSTIs.
"This is the first drug candidate designed specifically to treat this devastating disease."
According to a previously conducted Phase II trial, patients treated with AB103 showed consistent and meaningful improvements.
The company conducted a comprehensive retrospective NTSI study, which helped inform the design of the Phase III trial.
AB103 has already secured orphan drug and fast track designation from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The candidate’s development is being supported by a contract with the Biomedical Advanced Research and Development Authority (BARDA).