26th Apr 2016 11:16
LONDON (Alliance News) - Summit Therapeutics PLC Tuesday said that its investigation new drug application to expand its phase II proof of concept trial in Duchenne muscular dystrophy has been cleared by the US Food And Drug Administration.
This application was to expand the trial, dubbed PhaseOut DMD, to sites in the US. As such, the trial will now evaluate Summit's treatment candidate ezutromid in patients with the genetic disorder at sites in the UK and US.
Enrollment of patients in the US into the trial is expected in the third quarter of 2016.
"The IND clearance for PhaseOut DMD paves the way to expand PhaseOut DMD into the US and will provide access to a wider network of leading physicians in DMD as we seek to improve the lives of patients and families living with this devastating disease," said Chief Medical Officer Ralf Rosskamp in a statement.
Shares in Summit Therapeutics were up 4.9% at 111.75 pence Tuesday following the midday announcement, having been down at 103.65p prior.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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