Lead development, Metabolic Activity and Toxicity testing
- The pre-clinical chemical mimetic development focuses on a NRP molecule deriving from a large protein called CAPS-2 involved in vesicular protein excretion.
- The shortest amino acid chain providing all the desired bioactivities (go to background) is eleven amino acids long (NRP2945).
- Amino acid modification (chemical mimetic generation) has been performed to enhance the overall physico-chemical stability of the molecule.
- Currently, excellent stability over a timeframe of 1 year stored under sub-zero conditions has been achieved. CuroNZ has also achieved to create a liquid formulation (subcutaneous injection) for NRP2945. The stability of the liquid solution - injectable NRP2945 is suitable for early clinical trials.
- Metabolic activity in blood is sufficient long for penetration of NRP2945 through the blood brain barrier to exert its mechanism of action in a hit-and-run fashion on the CNS membrane receptors. NRP2945 is quickly (within 1 hour) eliminated from the CNS which provides high safety for future paediatric clinical trials.
A 28-day rat GLP toxicology / pharmacokinetic trial has been performed which delivered excellent safety and dose-response signals in the toxicokinetic study.
A 28-days dog GLP toxicology / pharmacokinetic study completed with emphasis on heart, lung physiology and IRWIN testing in brain tissue found no toxicity.