Reltecimod passes futility analysis in Phase III

Atox Bio Inc. (Ness Ziona, Israel) said an IDMC recommended continuation of the Phase III ACCUTE trial of reltecimod (AB103) to treat necrotizing soft tissue infections (NSTIs) in about 290 patients. The prespecified futility analysis evaluated safety and efficacy in the first 102 patients enrolled. The trial is evaluating 0.5 mg/kg IV reltecimod during or after surgical debridement plus the standard of care (SOC).

The double-blind, placebo-controlled, U.S. trial's primary endpoint is a clinical composite based on local and systemic components of the disease. Secondary endpoints include time to resolution of organ dysfunction, recovery from acute kidney injury (AKI) and health economic outcomes, such as days on ventilation, days in the ICU and duration of hospital stay...