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A Phase 3 Trial to Assess the Safety and Efficacy of Iclaprim in Patients with Hospital Associated Bacterial Pneumonia (HABP), Including Ventilator Associated Bacterial Pneumonia (VABP)

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Trial Profile

A Phase 3 Trial to Assess the Safety and Efficacy of Iclaprim in Patients with Hospital Associated Bacterial Pneumonia (HABP), Including Ventilator Associated Bacterial Pneumonia (VABP)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2019

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At a glance

  • Drugs Iclaprim (Primary)
  • Indications Nosocomial pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms INSPIRE
  • Sponsors Motif Bio

    • Most Recent Events

    • 10 Oct 2019 According to a Motif Bio media release, it would take several years to enroll and complete this HABP/VABP Phase III trial and the cost is expected to be tens of millions of dollars.The company is working hard to find a partner or other entity to complete this HABP/VABP Phase III trial and commercialise iclaprim.
    • 10 Oct 2019 According to a Motif Bio media release, the company has received the official minutes of the Type B meeting with the U.S. FDA which took place on 19th Sep 2019.As disclosed in the announcement on 30th Sep 2019, the minutes confirm that this single well-designed adequate and well-controlled Phase III clinical trial demonstrating safety and efficacy of iclaprim in patients with HABP, including VABP, along with data on potential mechanisms of hepatic injury, would enable submission of a NDA to FDA.
    • 12 May 2016 New trial record
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