Atox Bio Information

Atox Bio is a late stage, critical care immunotherapy company focusing on acute, life threatening, conditions with significant unmet need. The lead candidate in development is Reltecimod, an immunomodulator, which is designed to enhance the resolution of organ failure in conditions associated with severe acute inflammation such as necrotizing fasciitis (NF) and sepsis. Reltecimod completed enrollment in a phase 3, pivotal trial in patients with Necrotizing Soft Tissue Infections (also known as “flesh eating disease”). This is a life-threatening condition associated with high morbidity and mortality for which no therapy currently exists. In parallel, Reltecimod is also being studied in a phase 3, registrational study in patients with Sepsis Associated Acute Kidney Injury (SA-AKI). Acute kidney injury (AKI) is a common sequela of sepsis in the intensive care unit and the National Kidney Foundation estimates that ~50% of sepsis patients have AKI. This condition is associated with poor prognosis including increased short-term and long-term mortality. To date, no singular effective therapy has been developed to alter the natural history of SA-AKI Reltecimod received Orphan Drug designation from the FDA and EMA and Fast Track designation from the FDA.