ARTICLE | Clinical News

Drisapersen: Phase III restarted

October 6, 2014 7:00 AM UTC

Prosensa restarted dosing the 48-week, open-label, North American Phase III DEMAND V extension trial to evaluate 6 mg/kg subcutaneous drisapersen once weekly in up to 72 male patients ages >=5 years with DMD who had participated in the Phase II DEMAND V trial or the Phase III DEMAND III trial. 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). ...