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Krystal Biotech launches late-stage study on gene therapy in skin blistering disorder

Jul. 29, 2020 11:50 AM ETKrystal Biotech, Inc. (KRYS) StockKRYSBy: Vandana Singh, SA News Editor
  • Krystal Biotech (KRYS -3.2%initiates a pivotal Phase 3 (GEM-3) trial evaluating topical gene therapy bercolagene telserpavec (B-VEC) (previously KB103) for the treatment of dystrophic epidermolysis bullosa (DEB), a rare inherited disorder characterized by fragile skin that blisters easily.
  • The trial will evaluate the efficacy and safety of either B-VEC or placebo in ~30 in patients suffering from both recessive and dominant forms of DEB.
  • The primary endpoint is complete wound healing at weeks 20, 22 and 24 versus placebo.
  • The company expects to report topline data and file a U.S. marketing application in 2021.
  • The company also expects that its second GMP facility, ASTRA, will be operational in 1H of 2022.

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