As recently reported by the University of Virginia (link), a first-in-human clinical trial has begun evaluating hCitH3-mAb, a novel monoclonal antibody therapy targeting sepsis-induced acute respiratory distress syndrome (ARDS).

Sepsis and ARDS remain leading causes of mortality in intensive care units, with limited treatment options beyond supportive care. The investigational antibody was developed to neutralize citrullinated histone H3 (CitH3), a key driver of dysregulated immune responses and tissue damage in severe inflammatory disease.

According to coverage from UVA Research, the current Phase 1a study is designed to assess safety in healthy volunteers, with plans to advance into patients with sepsis-induced ARDS. The trial represents a significant translational milestone, moving a discovery from academic research into clinical evaluation.

Additional reporting from UVA Health highlights the scientific foundation of the program, including preclinical studies demonstrating that targeting CitH3 may reduce harmful inflammation without broadly suppressing immune function. Beyond sepsis and ARDS, the approach may have relevance for other severe inflammatory and immune-mediated conditions.