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Pharmacokinetics (PK) and shelf-life stability of NRP2945Drug Stability

  • Research done to date indicates that NRP2945 has excellent solubility in aqueous buffers and very long shelf-life stability when stored as lyophilisate under -20 0C ¬†conditions (>1.5 years). A developed proprietary liquid formulation (SC-injectable for ready injection) provides stability for 9 months under refrigerated conditions (after 270 days the chemical stability is 94.9%).
  • During the clinical phase 1 study NRP2945 has not shown any changes on the blood clinical chemistry or vital signs. Only mild injection site reactions were recorded. Overall, NRP2945 has a very low probability for human toxicity because the peptide shows the pharmacodynamics range in the low ng/ml range in blood plasma.
  • Dosing of NRP2945 only necessary as peripheral administration (SC) with potential long interval dosage (every 48 hrs)
  • Biological efficacy for NRP2945 (e.g. seizure control, ¬†improvement of motor scores as well attenuation of weight loss during neurodegenerative and cachexic bouts of disease) can be seen without the necessity of time consuming “built-up” drug titres in the blood stream because mechanism of action in the brain parenchyma of cell-penetrating peptide NRP2945 is facilitated by hit-and-run effect on novel neuronal chemokine receptor complex after crossing through the blood brain barrier.

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