Avidity Biosciences: FDA Eases Partial Clinical Hold on AOC 1001

By Chris Wack

Avidity Biosciences said Wednesday that the U.S. Food and Drug Administration has eased the partial clinical hold on AOC 1001, allowing Avidity to double the number of participants in its open-label extension study receiving 4 mg/kg of AOC 1001.

The company said the FDA also is allowing new participant enrollment for AOC 1001 at 2 mg/kg.

Data from the study will be used to finalize the AOC 1001 pivotal dose and Phase 3 study design for adults with myotonic dystrophy type 1.

In September 2022, the FDA placed a partial clinical hold on all new participant enrollment of AOC 1001 due to a rare serious adverse event reported in a single participant in the 4 mg/kg cohort of the Phase 1/2 trial.

Avidity said it remains on track to share a first look at the data from the study at the end of 2023.

Avidity shares were up 14% to $12.50 in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

May 17, 2023 07:33 ET (11:33 GMT)

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