GSK will report the phase III data of drisapersen at the World Muscle Society (WMS) meeting, 1-5 October, in the later breakers sessions.
Prosensa guided for reporting the phase 3 data of drisapersen in 4Q13 and the fact they tried to get the presentation at THE leading clinical muscle meeting suggests the data should be supportive for GSK. Hence we consider this as positive for Prosensa’s share in the coming weeks.
Last week, a paper in Neuromuscular Disorders reports about the data of drisapersen in non-ambulant subjects with DMD testing 3, 6, 9 and 12 mg/kg. Results were already released earlier. Single doses of drisapersen at 3 and 6 mg/kg did not result in significant safety or tolerability concerns; however, at the 9 mg/kg dose, pyrexia and transient elevations in inflammatory parameters were seen. The maximum tolerated dose of 6 mg/kg drisapersen was identified for further characterization in multiple dose studies in the non-ambulant DMD population. This finding is consistent with those from the ambulant DMD population, where the dose of 6 mg/kg/week is being studied in double-blind, placebo-controlled, 24 to 48 week studies of the efficacy and safety of drisapersen.
We expect supportive news flow in the coming weeks for Prosensa’s investment case. We refer to our company note published last week for other clinical results that will be published on Drisapersen and follow-up product PRO044. Buy rating and target price reiterated