Avidity Biosciences CSO Art Levin and CEO Sarah Boyce

FDA slaps a par­tial hold on Avid­i­ty's mAb-siR­NA ther­a­py, paus­ing en­roll­ment in mus­cle weak­ness dis­ease study

Avid­i­ty Bio­sciences will have to wait to en­roll new pa­tients in a Phase I/II study of its ther­a­py for my­oton­ic dy­s­tro­phy type 1, or DM1, which weak­ens mus­cles and leads to res­pi­ra­to­ry and car­diac is­sues.

The FDA is dock­ing new en­roll­ment in the MA­RI­NA study as the com­pa­ny and one of its tri­al in­ves­ti­ga­tors look in­to a se­ri­ous ad­verse event re­port­ed in a pa­tient in the 4 mg/kg co­hort, the biotech said Tues­day morn­ing. Pa­tients cur­rent­ly en­rolled can con­tin­ue on the study drug or place­bo and roll over in­to the open-la­bel ex­ten­sion.

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