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Avidity Biosciences: FDA Places Partial Hold on AOC 1001 Study

By Colin Kellaher

 

Avidity Biosciences Inc. on Tuesday said the U.S. Food and Drug Administration placed a partial clinical hold on new enrollment in a Phase 1/2 study of its lead product candidate after one participant suffered a serious adverse event.

The San Diego biopharmaceutical company said participants already enrolled in the study of AOC 1001 in adults with the genetic disorder myotonic dystrophy type 1 can continue in their current dosing cohort, but that it can't add any more participants until the partial hold is resolved.

Avidity said it is working closely with the FDA and the trial's investigator to assess the cause of the adverse event, adding that it is taking all necessary steps to resolve the partial hold on new study enrollment as quickly as possible.

The company said it is on track to conduct a preliminary assessment of safety, tolerability and key biomarkers in roughly half of the study's participants in the fourth quarter.

There are currently no approved treatment options for myotonic dystrophy type 1, a progressive and often fatal neuromuscular disease.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 27, 2022 07:39 ET (11:39 GMT)

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