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: 03 Nov 2025
Price :
$35
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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
- 15 Sep 2025 According to a Krystal Biotech media release, the company announced that the US FDA approved a label update for VYJUVEK, expanding its use to dystrophic epidermolysis bullosa patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings. This label update is based on real-world data collected since VYJUVEK launch in US, and results from the open label extension study conducted in the US and published earlier this year.
- 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.