Avidity: FDA Places Partial Clinical Hold On Participant Enrollment In Phase 1/2 MARINA Trial

Avidity Biosciences, Inc. (RNA) announced the FDA has placed a partial clinical hold on new participant enrollment in the phase 1/2 MARINA clinical trial of AOC 1001 in adults with myotonic dystrophy type 1. The partial clinical hold is in response to a serious adverse event reported in a single participant in the 4mg/kg cohort of the MARINA study. The company noted that all participants in MARINA may roll over into the MARINA-open label extension where they will receive AOC 1001 as planned.

Avidity said it remains on track to conduct a preliminary assessment of safety, tolerability and key biomarkers in approximately half of the study participants in the MARINA trial in the fourth quarter of 2022.

Shares of Avidity Biosciences are down 13% in pre-market trade on Tuesday.

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