Posted by Michael Wonder on 25 May 2018
U.S. FDA grants fast track designation for Krystal Biotech’s KB103 for the treatment of dystrophic epidermolysis bullosa
24 May 2018 - Krystal Biotech today announces that the U.S. FDA has granted fast track designation to KB103 for the treatment of dystrophic epidermolysis bullosa.
KB103 is the first-ever topically-applied herpes simplex virus based gene therapy engineered to deliver a human collagen protein to patients suffering from dystrophic epidermolysis bullosa.
A single-site, open-label, placebo-controlled Phase 1/2 clinical study of KB103 is underway at Stanford University. The study is designed to evaluate the safety and tolerability of KB103 using wound imaging, analysis of COL7 expression, and anchoring fibril formation.
