Posted by Michael Wonder on 26 Feb 2020
Translate Bio receives FDA fast track designation for MRT5005 for the treatment of cystic fibrosis
26 February 2020 - First inhaled mRNA therapeutic remains on track to report results from its ongoing multiple-ascending dose portion of Phase 1/2 clinical trial in the third quarter of 2020.
Translate Bio today announced that the U.S. FDA has granted fast track designation for MRT5005 for the treatment of cystic fibrosis (CF).
MRT5005, the first mRNA therapeutic with delivery to the lung, is designed to address the underlying cause of CF, regardless of genetic mutation, by delivering mRNA encoding fully functional cystic fibrosis transmembrane conductance regulator protein to cells in the lung through nebulisation.
