Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

Phase 3 Completed 290 enrolled Atox Bio Ltd Biomedical Advanced Research and Development Authority · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

Timeline

Start: 2015-12-01
Primary completion: 2019-08-18
Completion: 2019-10-18

Outcome

Missed primary endpoint

paper mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 PMID 32657946 ↗

paper significant improvement in the primary composite endpoint in the PP population but not in the mITT population. PMID 32657946 ↗

Publications

Results Bulger EM, May AK, Robinson BRH, Evans DC, Henry S, Green JM, Toschlog E, Sperry JL, Fagenholz P, Martin ND, Dankner WM, Maislin G, Wilfret D, Bernard AC; ACCUTE Study Investigators. A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). Ann Surg. 2020 Sep 1;272(3):469-478. doi: 10.1097/SLA.0000000000004102.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reltecimod	Peptide	0.5 mg/kg	Intravenous