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A pivotal Phase 3 study of KB103

Trial Profile

A pivotal Phase 3 study of KB103

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Bercolagene telserpavec (Primary)
  • Indications Epidermolysis bullosa
  • Focus Registrational; Therapeutic Use
  • Sponsors Krystal Biotech
  • Most Recent Events

    • 04 Nov 2019 According to an Krystal Biotech media release, the company expects to meet with the FDA before the end of 2019 to finalize trial design and endpoints for the upcoming pivotal trial of B-VEC.
    • 04 Nov 2019 According to an Krystal Biotech media release, the company plans to initiate manufacturing of their Phase 3 clinical material at the company's Ancoris GMP facility in early November and anticipate releasing this Phase 3 clinical material in 1Q 2020 and will initiate the B-VEC Phase 3 pivotal trial following release of Phase 3 material.
    • 05 Aug 2019 According to an Krystal Biotech media release, this trial is anticipated to start in Q4 2019, following discussions with the FDA.
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