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Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

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Trial Profile

Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2021

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At a glance

  • Drugs Reltecimod (Primary)
  • Indications Bacterial infections; Soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ACCUTE
  • Sponsors Atox Bio

Most Recent Events

  • 10 Dec 2020 According to Atox Bio media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted to file the New Drug Application (NDA) for reltecimod with a Prescription Drug User Fee Act (PDUFA) date of September 30, 2021.
  • 10 Jul 2020 According to an Atox Bio media release, study was funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201400013C.
  • 10 Jul 2020 According to an Atox Bio media release, manuscript of this study is now available from the Annals of Surgery as an ePublication.

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