Case Studies of Peptide Safety Assessment (S02-4)

In this presentation, examples of strategies and approached for peptide development projects at Novo Nordisk A/S will be outlined with specific focus on cases where peptide size and peptide modifications challenge the selection of an appropriate nonclinical strategy, while ensuring ethical development according to 3R principles, reduced use of resources in drug development and timely availability of new safe pharmaceuticals.
Examples include a) considerations around genotoxicity assessment and the use of in silico methods in lieu of in vivo testing and b) omission of hERG assays in safety pharmacology studies regardless of peptide size and/or whether the peptide molecule is considered a biotechnology derived product.
Further, approaches within general toxicity that follow recommendations described in ICHS6 are discussed for peptide molecules which, based on size and method of manufacture, would be regarded as small molecules. The examples comprise considerations related to duration of chronic toxicity studies in non-rodents or use of a single-species strategy for chronic toxicity studies