Atox Bio: Reltecimod passes Futility Analysis and will continue Phase 3

Atox Bio announced that Reltecimod (previously AB103) successfully completed pre-specified futility analysis in patients with Necrotizing Soft Tissue Infections and will continue further as planned without modification. It was decided after the recommendation made by an independent Data Monitoring Committee (DMC) after evaluating efficacy and safety data from the first 102 patients enrolled.

Atox Bio CEO, Dan Teleman said that they are making significant progress in their mission to develop the first therapeutic specifically approved for NSTI patients. They look forward to continued collaboration with all of the high caliber investigators and study coordinators who are participating in the trial.

Reltecimod (AB103) is a rationally designed peptide that binds to the CD28 co-stimulatory receptor to modulate the host’s immune response to severe infections. By limiting, but not inhibiting, the body’s acute inflammatory response, Reltecimod helps control the immune system in cases where an out of proportion response could otherwise quickly lead to morbidity and mortality. Reltecimod received Orphan Drug status from the FDA and EMA as well as Fast Track designation.

NSTIs is referred as “flesh eating bacteria”, represent the most severe, rare types of infections involving the skin, skin structure and soft tissues. NSTIs progress rapidly and often result in significant tissue destruction and systemic disease leading to multiple organ dysfunction, failure and death.