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Completed Phase I - Healthy male volunteer study

  1. 49 volunteers in 7 cohorts with single and multiple ascending dosages of NRP2945 (up to 25 ug/kg) fully formulated injectable-solution
  2. 5:2 ratio (NRP2945 vs Placebo)
  3. Safety (ECGs, vital signs and blood chemistry), tolerability (injection site reactions) during 28-days dosing (subcutaneous NRP2945-bolus every 48 hrs)
  4. NRP2945 was deemed safe and well tolerated
  5. No adverse events in vital signs, ECGs and only one event in blood chemistry (slightly elevated liver values for 2 subsequent days)
  6. Mild injection site reactions only in 20-25% of participants which were quickly resolved
  7. During 300 injection days less than 2% headaches and fatigue eventsMicroscope
  8. PK was dose-dependent with half-life between 22-25 min and non-accumulative
  9. Blood-based biomarker indicated receptor-based target engagement for NRP2945 in brain

Study Initiated for Absence Epilepsy Proof-of-Concept in Adults

  • Patients acutely injected subcut with NRP2945
  • Screening of generalized epileptic encephalopathy patients with absence epilepsy patterns
  • 3 cohorts (2 x dosages of NRP2945 and 1 x placebo arm) in a cross-over design
  • 2 subsequent injections (48 hrs apart)
  • EEG-controlled pharmacodynamics for safety and efficacy monitoring
  • Analysis of how quickly NRP2945 passes the human blood brain barrier
  • Blood chemistry and vital sign analysis
  • Blood-based biomarker dynamics to be measured after NRP2945 injections

First-line data to be expected in March/April 2019. Subsequently, preparations will be made to file an IND to get approval to trial NRP2945 in a paediatric population of patients diagnosed with Lennox-Gastaut Syndrome.

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