FDA Eases Partial Hold On Avidity Biosciences' Investigational Drug Study In Type Of Dystrophy
The FDA has eased the partial clinical hold on Avidity Biosciences Inc's (NASDAQ: RNA) AOC 1001, allowing Avidity to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001.
The FDA is also allowing new participant enrollment for AOC 1001 at 2 mg/kg.
The FDA placed a partial clinical hold on new participant enrollment in the trial in September last year.
Data from the MARINA-OLE study will be used to finalize the AOC 1001 pivotal dose and Phase 3 study design for adults with myotonic dystrophy type 1 (DM1), a fatal neuromuscular disease.
Avidity announced topline AOC 1001 data from the Phase 1/2 MARINA trial demonstrating directional improvement in multiple functional assessments, including myotonia, strength, and mobility measures.
In March, Avidity Biosciences decided to conclude the Phase 1/2 MARINA trial with the 38 participants enrolled at 1mg/kg, 2mg/kg, and 4mg/kg of AOC 1001 and not to move forward with the 8 mg/kg dose in myotonic dystrophy type 1 (DM1).
Avidity remains on track to share a first look at the data from the MARINA-OLE study at the end of 2023.
Price Action: RNA shares are up 1.60% at $11.13 on the last check Wednesday.
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