Σάββατο, 15 Νοεμβρίου 2014

Neuren’s NNZ-2566 successful in demonstrating clinical benefit in Rett syndrome Phase 2 trial

Neuren’s NNZ-2566 successful in demonstrating clinical 

benefit in Rett syndrome Phase 2 trial

Highlights:

• Achieved primary endpoint - both dose levels of NNZ-2566 were well tolerated after 28 days of

treatment and no safety concerns were identified

• Higher dose (70mg/kg twice daily) exceeded the pre-specified criteria for improvement in core

efficacy measures compared with placebo

• The clinical benefit in the trial encompassed core symptoms of Rett syndrome and was observed

in both clinician and caregiver assessments

• Meeting with FDA expected in Q1 2015 to discuss further development in Rett syndrome

• Results will enable applications for both Orphan Drug and Breakthrough Therapy designation


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