Update from GSK on the progress of their drisapersen (previously GSK2402968) clinical development program:
To keep you current on the progress of the drisapersen (previously GSK2402968) clinical development program, as you have requested, I am writing to inform you that the last patient has been recruited within the drisapersen US Phase II clinical study [www.clinicaltrials.gov NCT01462292]. This exploratory study aims to assess the safety, efficacy and pharmacokinetics of two doses of drisapersen in the treatment of ambulant boys with DMD who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of all boys with DMD). The Primary Outcome Measure is mean change from baseline of the distance that the patient can walk in 6 minutes (measurement performed through the standardised 6 Minutes Walk Distance Test- 6MWDT) following the 24 week treatment period, and the study also has a 24 week post-treatment phase for continued monitoring. The study is expected to complete in November 2013, with study results available in early 2014. The results will be presented at the first appropriate medical conference.
Should you have any additional questions, please let us know. You can also find more information regarding the ongoing clinical studies involving drisapersen, by visiting www.clinicaltrials.gov.