FDA par­tial­ly lifts dos­ing hold on Stoke Ther­a­peu­tic­s' pe­di­atric Dravet syn­drome study

RNA play­er Stoke Ther­a­peu­tics said Wednes­day that the FDA par­tial­ly lift­ed a clin­i­cal hold on a Phase I/IIa study in chil­dren and ado­les­cents with Dravet syn­drome, al­low­ing the com­pa­ny to in­crease the test­ed dose of its lead drug.

Stoke spokesper­son Dawn Kalmar tells End­points News the hold dates back to March 2020 when the com­pa­ny first got clear­ance to start Phase I/II stud­ies test­ing can­di­date STK-001 in Dravet syn­drome pa­tients. The de­ci­sion to put the par­tial hold in place was based on pre­clin­i­cal da­ta, Kalmar added.

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