Krystal Biotech Gets FDA Nod For Initial-Stage Lung Infection Study

The United States Food and Drug Administration (FDA) has accepted Krystal Biotech’ KRYS Investigational New Drug (IND) application to evaluate KB407 in a clinical trial for cystic fibrosis (CF).

The Company submitted an IND application to initiate the Phase 1 clinical trial of KB407 in July 2022.

KB407 is a modified HSV-1 vector carrying two copies of the cystic fibrosis transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.

Hubert Chen, Senior Vice President of Clinical Development, commented: "We are excited to advance KB407, our investigational gene therapy for patients with CF, into the clinic. It is designed to treat the root cause of the disease regardless of an individual patient's mutation by giving the body instructions to produce its own functional protein. In addition, this IND acceptance represents an important milestone for us as it allows us to demonstrate the power of our platform to deliver genes, beyond skin cells, to respiratory cells.”

Krystal Biotech is planning to initiate the clinical trial in the second half of 2022.

Cystic fibrosis (CF) is a genetic disease, affecting people of every racial and ethnic group, by causing a buildup of mucus in the lungs leading to persistent lung infections and progressive pulmonary disease.

Price Action : Krystal Biotech shares closed Friday’s trading at $72.58