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Discovery Pipeline Pharmacodynamics Publications

Clinical Studies 

Curonz has conducted the following clinical trials on NRP2945 in humans. Both studies were completed in Australia under the TGA guidelines.

Clinical Phase I

Clinical Phase I randomized double-blind safety / tolerability and PK study with healthy male volunteers:

  • 49 (+3 replaced drop-outs) male volunteers in 7 cohorts with single and multiple ascending dosages of NRP2945 (from 1- 25 ug/kg) fully formulated injectable-solution of NRP2945 dosed in a 27 days SC-injection study.
  • A 5:2 ratio of NRP2945 vs Placebo.
  • Safety (ECGs, vital signs and blood chemistry), tolerability (injection site reactions) during 28-days dosing (subcutaneous NRP2945-bolus every 48 hrs).
  • NRP2945 was deemed safe and well tolerated.
  • No adverse events in vital signs, ECGs and safety blood.
  • Mild injection site reactions only in 20-25% of participants which were quickly resolved.
  • During 300 injection days less than 1.5 % headaches and 2% fatigue events.
  • PK was dose-dependent with half-life between 22-25 min and non-accumulative with a Cmax of 1-1.5 ng/ml.
  • Blood-based biomarker indicated receptor-based target engagement for NRP2945 in brain.

Clinical Phase IIa - Absence Epilepsy

In 2019, CuroNZ conducted a proof-of-concept study (phase IIa) with heavily drug-resistant Genetic Generalized Absence Epilepsy patients in Melbourne (Australia). The drug candidate was again well tolerated and after only 4 subcutaneous bolus injections the majority of drug-resistant patients achieved seizure freedom in the range between 10-60 days.

Outline and achieved clinical phase IIa data are summarized as follows:

  1. Screening of generalized epileptic encephalopathy patients with absence epilepsy patterns that are uncontrolled by 3 previously administered AEDs.
  2. Patients acutely subcutaneously injected with NRP2945 in a cross-over design study.
  3. Three cohorts (1 x placebo arm and 2 x dosages of NRP2945) in a cross-over design.
  4. EEG-controlled pharmacodynamics for safety and efficacy monitoring revealed seizure freedom after cohort 3 dosing and immediate downregulation of epileptiform activity profiles.
  5. NRP2945 passes the human blood brain barrier within minutes because of dropping cumulative seizure rate within 30 min after NRP2945 injection.
  6. Blood chemistry and vital sign analysis showed maximal safety.
  7. Seizure reductions for all patients.
  8. Seizure freedom achieved for the majority of patients (ranging from 10-60 days).