Krystal Biotech to Present Additional Data on B-VEC from the GEM-3 Phase 3 Study at the Society for Investigative Dermatology Annual Meeting
GEM-3: phase 3 safety and immunogenicity results of beremagene geperpavec (B-VEC), an investigational, topical gene therapy for dystrophic epidermolysis bullosa (DEB)
Poster Session 1
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ePoster Presentation: Session 2, Genetic Disease, Gene Regulation, and Gene Therapy
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The poster and ePoster will be available to conference attendees. To register for the conference, please visit SID 2022 Annual Meeting | Society for Investigative Dermatology. The Company will be present at Booth 218 to educate about DEB and the mechanism of the disease. Following the presentation, materials will be available to view online on the Investor section of the Company’s website.
About Dystrophic Epidermolysis Bullosa (DEB)
DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal.
B-VEC is an investigational non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. B-VEC was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted B-VEC an orphan drug designation for the treatment of DEB. The FDA has also granted B-VEC fast track designation and rare pediatric designation for the treatment of DEB. In addition, in 2019, the FDA granted Regenerative Medicine Advanced Therapy (“RMAT”) to B-VEC for the treatment of DEB and the EMA granted PRIority MEdicines ("PRIME") eligibility for B-VEC to treat DEB.
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Source: Krystal Biotech, Inc.