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: 05 May 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
- 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.
- 09 Dec 2024 According to a Krystal Biotech media release, company announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company Marketing Authorization Application for beremagene geperpavec-svdt (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) that was scheduled for December 6, 2024, and asked the Company to submit written responses to the remaining outstanding issues.