Rockville-based Therabron Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing a new standard in respiratory care, announced that it has received Fast Track Designation from the U.S. FDA for rhCC10 (recombinant human Club Cell 10 kDa Protein), specifically for the prevention of chronic lung disease related to premature birth.

Therabron Therapeutics’ lead biopharmaceutical product candidate is a proprietary preparation of recombinant human CC10 protein which has potential clinical applications, based on its potent anti-inflammatory properties, in a variety of respiratory diseases. CG100, the company’s lead compound based on rhCC10 and intended to prevent chronic lung disease in neonates, is currently in a Phase 2 clinical trial enrolling 88 preterm infants. This ongoing Phase 2 study is supported, in part, by a grant from the U.S. FDA Office of Orphan Product Development.

 

Reference:

http://therabron.com/wp-content/uploads/2016/04/Press-release-Therabron-Fast-Track-Designation-FINAL-428.pdf