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Second phase 3 study of AR-301 for the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

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Trial Profile

Second phase 3 study of AR-301 for the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2023

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At a glance

  • Drugs Tosatoxumab (Primary)
  • Indications Community-acquired pneumonia; Nosocomial pneumonia; Staphylococcal infections; Ventilator associated pneumonia
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 17 Jul 2023 According to an Aridis Pharmaceuticals media release, company received positive agreement and feedback from European Medicines Agency (EMA) on clinical design of this confirmatory Phase 3 study of AR-301.
  • 31 May 2023 According to an Aridis Pharmaceuticals media release, the FDA agreed to the proposed expansion of the trial in S. aureus ventilator associated pneumonia (VAP) patients to include ventilated hospital acquired pneumonia (HAP) and ventilated community acquired pneumonia (CAP) patients.
  • 31 May 2023 According to an Aridis Pharmaceuticals media release, FDA agreed on the design of this single confirmatory Phase 3 superiority study required to support the submission of a Biologics License Application (BLA).

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