Krystal Biotech Announces FDA Clearance of IND on KB103 to Begin Enrolling Patients for the Treatment of Dystrophic Epidermolysis Bullosa

Krystal Biotech (NASDAQ:KRYS), a gene therapy company developing topical and intradermal “off-the-shelf” treatments for rare dermatological diseases, today announces the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for lead product candidate KB103. KB103 is the first-ever topical herpes simplex virus (HSV-1) based gene therapy engineered to deliver a human collagen protein to patients suffering from dystrophic epidermolysis bullosa (DEB).

As quoted in the press release:

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.

“We are excited about KB103 entering the clinic. Our goal is to demonstrate that KB103 could truly be a first-in-class potent treatment for DEB that has the potential to change the lives of people affected by this condition,” said Suma Krishnan, founder and chief operating officer of Krystal. “We plan on enrolling patients in this Phase 1/2 study as soon as we can and hope to have a meaningful data readout shortly.”

“Clearance of the IND by the FDA is the first of several important milestones for the KB103 program,” said Krish Krishnan, chairman and chief executive officer of Krystal. “I am proud of the efforts of the Krystal team that has worked diligently to bring KB103 into the clinic in a timely manner. We are excited about the possibility of providing a simple topically-applied treatment to fundamentally treat this debilitating disease.”

Click here to read the full press release.