GSK, Prosensa Say Primary Endpoint Not Met In Phase III Study Of Drisapersen

(RTTNews) - GlaxoSmithKline(GSK, GSK.L), and Prosensa(RNA), Friday said that GSK's Phase III clinical study of an investigational antisense oligonucleotide, drisapersen, did not meet the primary endpoint of a statistically significant improvement in the 6 Minute Walking Distance test compared to placebo. Drisapersen, which was recently granted the Breakthrough Therapy designation, is being studied for the treatment of Duchenne Muscular Dystrophy patients with an amenable mutation.

The companies said that the full evaluation of the benefit-to-risk profile of drisapersen treatment across all studies is anticipated to be completed by year end, which may include analysis of pooled results from various drisapersen studies.

GSK obtained an exclusive worldwide license to develop and commercialize drisapersen from Prosensa in 2009. Drisapersen also was granted an orphan drug status in EU, US and Japan. Drisapersen is not approved or licensed for use anywhere in the world.