Krystal Biotech Inc KRYS has announced positive topline results from the GEM-3 Phase 3 trial of investigational beremagene geperpavec (B-VEC, Vyjuvek) for dystrophic Epidermolysis Bullosa (dystrophic EB).
- DEB is a genetic skin disorder affecting skin and nails that cause the skin to be very fragile and to blister easily.
- Blisters and skin erosions form in response to minor injury or friction, such as rubbing or scratching.
- Vyjuvek is a non-invasive, topical, and redosable gene therapy.
- 67% of wounds treated with Vyjuvek achieved the primary endpoint of investigator-assessed complete wound healing at the six-month timepoints compared to 22% of wounds treated with placebo.
- 71% of wounds treated with Vyjuvek achieved the secondary endpoint of complete wound healing at the three-month timepoints compared to 20% of wounds treated with placebo.
- Vyjuvek was well tolerated. No drug-related serious adverse events or discontinuations due to treatment were reported.
- During the trial, one mild drug-related adverse event was reported.
- Krystal plans to file an FDA marketing application in 1H of 2022 and a European application shortly after.
- Also See: Krystal Biotech’s KB105 Shows Detectable, Functionally Active TGM-1 Enzyme In Genetic Skin Condition.
- Price Action: KRYS shares are up 114.30% at $85.31 during the premarket session on the last check Monday.
Originally Posted on November 29, 2021 – Krystal Biotech Shares More Than Double During Premarket Monday: What Investors Need To Know
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