Avidity Biosciences Reports the US FDA's Clinical Hold on P-I/II (MARINA) Trial of AOC 1001 for Myotonic Dystrophy Type 1
Shots:
- The US FDA has placed a partial clinical hold on new patient enrollment in the P-I/II (MARINA) trial of AOC 1001 for DM1. 40 patients enrolled in (MARINA) & (MARINA-OLE) trials may continue to be treated with AOC 1001
- The US FDA’s decision was based on the serious AEs reported in a single patient in the 4mg/kg cohort of the (MARINA) study & no additional patients may be enrolled until the partial clinical hold is resolved
- The company works closely with the US FDA and the trial investigator to determine the next steps to resolve the partial clinical hold for new patient enrollment shortly. The preliminary assessment of the (MARINA) study is expected in Q4’22 & the company also advances AOC 1020 for FSHD & AOC 1044 for DMD into the clinic in 2022
Ref: Avidity Biosciences | Image: Avidity Biosciences
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