Shares of Avidity Biosciences (NASDAQ: RNA) tanked in pre-market trading on Tuesday as the company announced that the U.S. Food and Drug Administration (FDA) had placed a partial clinical hold on new participant enrollment in the Phase 1 MARINA clinical trial.
Avidity Biosciences is developing a new class of RNA therapeutics – Antibody Oligonucleotide Conjugates (AOCs). AOCs are a novel class of synthetic biomolecules that are increasingly being used in the field of biotechnology.
The FDA’s partial clinical hold was in response to a “serious adverse event reported in a single participant in the 4mg/kg cohort of the MARINA study.”
The Phase 1 MARINA clinical trial is of Antibody Oligonucleotide Conjugates (AOC) 1001 in adults with myotonic dystrophy type 1 (DM1). Myotonic dystrophy is a disorder with progressive wasting and weakness of muscles.
Currently, 40 patients have enrolled in the MARINA and MARINA open-label extension (MARINA-OLE) trials.
