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Phase 3 study of SYN-004 for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and emergence of antibiotic-resistant organisms

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Trial Profile

Phase 3 study of SYN-004 for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and emergence of antibiotic-resistant organisms

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2018

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At a glance

  • Drugs Ribaxamase (Primary)
  • Indications Clostridium difficile infections; Diarrhoea
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Theriva Biologics

    • Most Recent Events

    • 21 Nov 2018 According to a Synthetic Biologics media release, the FDA has proposed criteria for Phase 3 clinical efficacy and safety which, if achieved, may support submission for marketing approval of ribaxamase.
    • 08 Aug 2018 According to a Synthetic Biologics media release, company anticipates End-of-Phase 2 meeting with the FDA in 3Q 2018 to solidify elements of the trial.
    • 23 Apr 2018 According to a Synthetic Biologics media release, company is planning to include patients population of additional IV beta-lactam antibiotics with ceftriaxone and by enrolling patients with a variety of underlying infections.

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