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A Phase I/II Study of KB103, a Non-Integrating, Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein, for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

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Trial Profile

A Phase I/II Study of KB103, a Non-Integrating, Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein, for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 07 Aug 2025

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At a glance

  • Drugs Beremagene geperpavec (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms GEM-1; GEM-2
  • Sponsors Krystal Biotech

Most Recent Events

  • 04 Aug 2025 According to a Krystal Biotech media release, VYJUVEK has been approved by European Commission (EC) for the treatment of wounds in patients with DEB.
  • 28 Apr 2025 According to a Krystal Biotech media release, based on result form GEM-1 and GEM-3 studies further supported by open label extension study and real-world experience in the United States, the European Commission granted marketing authorization to beremagene geperpavec-svdt for the treatment of wounds in patients with dystrophic epidermolysis bullosa who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth.
  • 28 Feb 2025 According to a Krystal Biotech media release, based on result form GEM-1, GEM-2 trials Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the European Commission (EC) to approve VYJUVEK(beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth.

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