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 :
"The very prominent responder effect, as well as the significant reductions in OFF-time and troublesome dyskinesia observed in trial 006, are extremely encouraging and demonstrate the substantial potential for ND0612 to make a meaningful difference in the lives of patients living with Parkinson's disease," said Oded S. Lieberman, PhD, CEO of NeuroDerm. "We believe that restarting and amending the iNDiGO trial, incorporating both an ND0612H arm and new endpoints that reflect these very positive preliminary results from trial 006, should support a broader label in the EU and increase the clinical and commercial potential of ND0612 while not affecting our clinical timelines. We are committed to improving the lives of Parkinson's patients by achieving our clinical and regulatory objectives as quickly as possible and providing Parkinson's disease patients with a safer and more effective alternative to current treatment options."
- Trial 006 demonstrated a statistically significant and clinically meaningful reduction in OFF-time and increase in proportion of patients "ON" by 8:00 am (primary and key secondary endpoints).
- The trial also showed statistically significant reduction in troublesome dyskinesia and a complete reduction of OFF-time to zero hours in 66% of responders (post hoc sub-groups analyses).
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