KRYS - Krystal Biotech provides update on pivotal GEM-3 study of B-VEC for DEB

Krystal Biotech (KRYS) announces modifications to the Statistical Analysis Plan ((SAP)) in the ongoing Phase 3 study of B-VEC for the treatment of dystrophic epidermolysis bullosa ((DEB)) based on feedback from the U.S. FDA.The trial is a randomized, double-blind, intra patient placebo-controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for patients living with both recessive and dominant forms of DEB.To account for paired binary data in the study design and the within-pair correlation in the GEM-3 study, Krystal will use the McNemar test for primary efficacy analysis.The primary outcome measure is complete wound healing determined by the Investigator in B-VEC treated wounds versus placebo.In the updated SAP, a positive response is defined as a complete wound healing at Week 22 and Week 24, or complete wound healing at Week 24 and Week 26.Only wounds that achieve complete wound healing for at least 2 weeks are counted as

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Krystal Biotech provides update on pivotal GEM-3 study of B-VEC for DEB