Wave Life Sciences Duchenne Muscular Dystrophy Clinical Trial Selected for FDA Complex Innovative Trial Designs Pilot Program | DuchenneXchange

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Wave Life Sciences Duchenne Muscular Dystrophy Clinical Trial Selected for FDA Complex Innovative Trial Designs Pilot Program


Wave Life Sciences Ltd., a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced that the planned Phase 2/3 efficacy and safety trial for its lead Duchenne muscular dystrophy (DMD) clinical program has been selected for the U.S. Food and Drug Administration (FDA) pilot program for complex innovative trial designs (CID). The selection was based on the design of Wave’s Phase 2/3 clinical trial of suvodirsen (WVE-210201), an investigational therapy for boys with DMD who are amenable to exon 51 skipping. This marks the first time that the FDA has selected clinical protocols for its CID pilot program that was announced in August 2018.

Wave Life Sciences Duchenne Muscular Dystrophy Clinical Trial Selected For FDA Complex Innovative Trial Designs Pilot Program