Reducing Non-Human Primates in Non-Clinical Safety Assessment: The European Initiative on Minipig and Micropig Models

Non-human primates remain essential in the safety testing of new drug candidates, as their genetic, biological, and behavioural similarities to humans provide critical insights into the safety, efficacy, and potential side effects of these drugs. The EU Directive 2010/63/EU underlines the importance of ethical animal research, encouraging for the replacement, reduction, and refinement of animal use while acknowledging that certain complexities of human biology can only be effectively studied in non-human primates.

NHPig is an EU-funded research project aimed at transforming non-clinical safety assessment by use of mini- and micropig models. The goal is to expand and share biological knowledge on mini- and micropig models and improve the translational understanding between pig models and non-human primates (NHPs) and humans with the possibility to use these pig models as viable alternatives to NHPs in the nonclinical safety testing.

NHPig is a 5-year European public-private partnership backed by €17.5 million in funding from the Innovative Health Initiative Joint Undertaking and contributing private industry partners. The project consortium brings together leading international experts from 27 partner organisations led by the Ludwig-Maximilians-Universität München (Germany) and Novo Nordisk A/S (Denmark).

The start of NHPig is a big step forward for science and animal welfare in the EU. This project uses mini- and micropig models to lessen our reliance on non-human primates for research and to overall refine and reduce the use of animals and promote ethical scientific practices in biomedical research.

NHPig is committed to promote the 3R principles (Replacement, Reduction and Refinement) by developing a comprehensive knowledge and technology base, including:

Creating a database and IT platform for comparing mini-/micropig data across species.
Characterizing humanized IgG1/4 minipigs and micropigs for tolerance to human therapeutic antibodies and investigate the feasibility of these pig models in non-clinical safety testing.
Establishing biobanks of wildtype and genetically modified minipigs and micropigs and collecting multi-omics data for biomarker discovery and safety/efficacy assessment including using AI-driven analytical methods.
Characterising the porcine immune system and immune response following treatment with human therapeutics, by expanding tools for pigs and further developing in vitro models to reduce animal use in drug development.
Enhancing preclinical toxicity studies by developing and qualifying AI-integrated digital solutions, that objectively measure clinically relevant biomarkers, fully compliant with regulatory requirements.