CureDuchenne Ventures’ early funding of Edgewise in September of 2019 is returning more good news. In November of 2020, Edgewise began its Phase 1 clinical trial on EDG-5506, an experimental therapeutic aimed at minimizing muscle fiber damage in Duchenne and Becker muscular dystrophies. Today, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the experimental drug for the treatment of Becker muscular dystrophy, based on a robust preclinical data package and their ongoing Phase 1 clinical trial.
Edgewise’s approach is a novel strategy for treating Becker and Duchenne muscular dystrophy and has the potential to benefit all individuals no matter what mutation they carry. It could also prove to be additive with other therapies aimed at restoring dystrophin. CureDuchenne held a webinar with Edgewise in February of 2021 which explains their approach in greater depth, and you can read more details about today’s U.S. FDA Fast Track Designation for EDG-5506 in Edgewise’s press release here.
CureDuchenne congratulates Edgewise on this important regulatory milestone, and their ongoing commitment to address the important unmet medical needs in both Becker and Duchenne muscular dystrophies.