ARTICLE | Clinical News

Drisapersen: Phase II restarted

October 6, 2014 7:00 AM UTC

Prosensa restarted dosing in an open-label, European Phase II extension trial to evaluate subcutaneous 6 mg/kg drisapersen once weekly in 12 male patients ages 5-16 years with DMD who previously participated in the study. All dosing in the drisapersen clinical program had been placed on hold in September 2013 by GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.) after announcing data from double-blind, international Phase III DEMAND 3 (DMD114044) trial, which showed that drisapersen missed the primary endpoint of improving 6MWD from baseline to week 48 vs. placebo (see BioCentury, Sept. 23, 2013). In January, GSK returned rights to drisapersen to Prosensa (see BioCentury, Oct. 19, 2009 & Jan. 20, 2014). ...