KRYS - Krystal Biotech says study on VYJUVEKTM for rare skin disease met primary endpoint

Announcing topline data from its pivotal GEM-3 trial for its experimental therapy, VYJUVEK dystrophic Epidermolysis Bullosa (dystrophic EB), Krystal Biotech (NASDAQ:KRYS) said the study met the primary endpoint with statistical significance. In reaction, shares of Krystal Biotech (KRYS) have climbed ~124.2% in the pre-market on above-average volume. In the 31-patient study, 67% of wounds treated with the topical gene therapy — previously known as beremagene geperpavec (B-VEC) — reached the primary endpoint showing complete wound healing at the six months vs. 22% in the wounds that received the placebo. (p<0.005) At the three-month time point, 71% of wounds treated with VYJUVEK showed investigator-assessed complete wound healing, therefore, achieving the secondary endpoint, compared to 20% of wounds treated with placebo. Except for one mild drug-related adverse event, the treatment indicated a favorable safety profile, and there were no drug-emergent serious adverse events or discontinuations, according to the company. A Biologics License Application (BLA) with

For further details see:

Krystal Biotech says study on VYJUVEKTM for rare skin disease met primary endpoint