KB103 is the first-ever topically-applied herpes simplex virus (HSV-1) based gene therapy engineered to deliver a human collagen protein to patients suffering from DEB.
 

DEB is a chronic, progressive and incredibly painful skin disease caused by mutations in the gene coding for type VII collagen, or COL7. As a result of mutated COL7, DEB patients’ skin is incredibly fragile, resulting in blistering or skin loss at the slightest friction. There are currently no approved treatments for DEB.

“This Fast Track designation represents another positive step for the development of KB103 and is a clear recognition of the serious unmet need that exists for patients suffering from this debilitating disease,” said Suma Krishnan, founder and chief operating officer of Krystal.  

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.