(RTTNews) - Avidity Biosciences (RNA) announced the FDA has removed the partial clinical hold on delpacibart etedesiran, an investigational treatment designed to address the root cause of myotonic dystrophy type 1. Del-desiran is being evaluated in the Phase 3 HARBOR trial in patients with dystrophy type 1.
Del-desiran or AOC 1001, Avidity's lead product candidate utilizing its AOC platform, is designed to address the root cause of dystrophy type 1 by reducing levels of a disease-related mRNA called DMPK. Del-desiran has received Breakthrough Therapy, Orphan Drug and Fast Track designations by the FDA and Orphan designation by the European Medicines Agency.
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