Solid Biosciences Inc., which acquired UF startup AavantiBio, announced a positive regulatory update from its recent Type C meeting with the U.S. Food and Drug Administration (FDA) that supports the continued advancement of SGT-003 as a potential treatment for Duchenne muscular dystrophy.
Solid reached alignment with the FDA on the overall study design for the Company’s randomized, double-blind, placebo-controlled Phase 3 clinical trial, IMPACT DUCHENNE. The FDA agreed that the trial design was reasonable including: the patient population of ambulant participants 7 to <12 years of age, the primary endpoint of change from baseline in Time to Rise (TTR) velocity from supine position evaluated at 18 months and other key secondary endpoints.
Read more about Solid Biosciences Announces Positive Feedback From Type C Meeting With FDA for SGT-003 Gene Therapy for Duchenne Muscular Dystrophy.
