Precision BioSciences announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for a gene editing therapy for Duchenne muscular dystrophy. This clearance allows the company to move forward with a Phase 1/2 clinical study to evaluate safety and early signals of effectiveness.
The investigational therapy uses Precision’s ARCUS® gene editing platform and is designed to directly edit the dystrophin gene in muscle tissue. Notably, this program represents the first in vivo gene editing approach intended to potentially treat up to 60% of individuals living with Duchenne.
While this is an early step, FDA clearance to begin clinical testing marks important forward momentum for the Duchenne community.
Read the news release HERE
The post Precision BioSciences announced that the U.S. FDA has cleared its Investigational New Drug (IND) appeared first on CureDuchenne.