Prosensa Holding RNA commented on a recent update by
GlaxoSmithKline GSK to patient groups and investigators regarding
the ongoing analyses for drisapersen, an investigational antisense
oligonucleotide, for the treatment of Duchenne Muscular Dystrophy
(DMD) patients with an amenable mutation, which is exclusively
licensed to GSK.On September 20, GSK and Prosensa announced that results of a
Phase III study (DMD114044) of drisapersen in boys with DMD did not
meet the primary endpoint. At that time, together with Prosensa,
GSK began to evaluate the results in the context of the overall
clinical program in addition to performing additional analyses to
fully understand the results of this study. Earlier today, GSK provided an update to patient groups and
investigators that the analysis of the results and assessment of
next steps are still ongoing. The outcome of this evaluation is
anticipated in early 2014. In addition, as publicly announced
at the recent PPMD Duchenne Policy Forum, the US Food and Drug
Administration is currently looking at the drisapersen data, in
part to understand clinical and biomarker endpoints.
In the meantime, GSK has stated that as per their policy, the
summary results of the DMD114044 study will be posted on
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