March 1, 2017 / 1:14 PM / 5 months ago

BRIEF-NeuroDerm achieves primary goal in ND0612H Phase II Trial for advanced Parkinson's disease

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March 1 (Reuters) - NeuroDerm Ltd

* NeuroDerm achieves primary endpoint in ND0612H Phase II trial for advanced Parkinson's disease; seeks broader EU label based on indigo trial following EMA Meeting

* NeuroDerm Ltd - trial 006 demonstrated a statistically significant and clinically meaningful reduction in off-time

* Says preliminary analysis of trial 006 demonstrated that trial successfully met its primary, key secondary and additional secondary endpoints

* NeuroDerm - Trial showed statistically significant reduction in troublesome dyskinesia, complete reduction of off-time to zero hours in 66% of responders

* NeuroDerm Ltd- NeuroDerm's iNDiGO phase III efficacy study (trial 007) will be restarted and amended to support a broad label claim in EU for ND0612

* Says has modified its EU clinical and regulatory development strategy following a meeting with European Medicines Agency

* NeuroDerm Ltd- It is anticipated that iNDiGO will be completed in 2018, in parallel to ongoing long term beyond safety trial (trial 012)

* NeuroDerm achieves primary endpoint in ND0612H phase II trial for advanced Parkinson's disease; seeks broader EU label based on iNDiGO trial following EMA Meeting Source text for Eikon: Further company coverage:

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