Therabron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to rhCC10 (recombinant human Club Cell 10 kDa Protein), the company’s lead product candidate,for the prevention of bronchopulmonary dysplasia and chronic respiratory morbidity (CRM) in preterm infants. The Rare Pediatric Disease Designation supplements the Fast Track Designation recently granted by the FDA for rhCC10. This program has also previously been granted Orphan Status by both the US and EU Health Authorities.
Thomas F. Miller, PhD, MBA, President and Chief Executive Officer of Therabron, noted, “We are extremely pleased that the FDA, in support of drug development for rare pediatric diseases, has granted rhCC10 this designation for condition conditions where there are no available treatment options and several unmet medical needs persist.”
Last week, the Company announced it has completed enrollment of its phase 2 clinical trial
evaluating its lead product candidate, CG100, for the prevention of CRM in premature infants.
CG100 is based on Therabron’s recombinant rhCC10 protein. The Company plans to unblind the trial dataset mid-next year and continue its work to advance this product candidate toward phase 3 development. This phase 2 trial has been supported, in part, by a grant from the U.S.FDA Office of Orphan Product Development.
