NHPig

Reducing non-human primates in non-clinical safety assessment: The European initiative on minipig and micropig models

Summary

Before a new medicine is tested in humans for the first time, researchers carry out a range of tests to ensure the medicine is safe. While many of these tests involve (for example) cells in petri dishes or computer-based tests, some tests still involve the use of animals including, in certain cases, non-human primates (NHPs).

Because NHPs are so closely related to humans, the results of tests involving NHPs are often a reliable indicator of how a medicine will work in humans. At the same time, NHPs’ similarity to us means that their use in research & development raises significant ethical issues. For this reason, EU law only allows the use of NHPs when no alternative is available.

More broadly, the EU encourages research designed to develop alternatives to the use of NHPs, and that’s where NHPig comes in.

NHPig aims to further reduce the use of NHPs by replacing them with mini- and micro-pigs in non-clinical safety studies. Today, we do not have enough scientific knowledge and dedicated tools to use pigs in these studies; NHPig will fill this gap.

Among other things, NHPig will do this by performing a detailed characterisation of minipigs that are already used in research and address knowledge gaps on pigs’ immune system. They will also develop new tools to further study non-clinical safety issues in minipigs, including validated antibodies and biomarkers for liver and kidney toxicity. Part of the project will focus on developing non-invasive sensors that would allow the physiology and behaviour of mini-/micropigs to be monitored continuously. The project hopes this will make it easier to evaluate the effects of new treatments on major physiological systems. The project will set up a regulatory advisory board and an ethics and animal welfare advisory board to ensure compliance with EU rules on the use of animals in research & development.

One key project output will be a publicly available database and IT platform comprising both existing information on mini/micropigs, NHPs and humans and data generated during the project.

Participants

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Universities, research organisations, public bodies, non-profit groups
  • Aarhus Universitet, Aarhus C, Denmark
  • Eidgenoessisches Departement Des Innern, Bern, Switzerland
  • Karolinska Institutet, Stockholm, Sweden
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany
  • Technische Universitaet Muenchen, Muenchen, Germany
  • Universiteit Antwerpen, Antwerp, Belgium
  • Ustav Zivocisne Fyziologie A Genetiky Av Cr V.V.I., Libechov, Czechia
  • Veterinaermedizinische Universitaet Wien, Wien, Austria
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Avantea SRL, Cremona, Italy
  • Biotalentum Tudasfejleszto Kft, Goedoello, Hungary
  • Ellegaard Gottingen Minipigs As, Dalmose, Denmark
  • Etisense, Lyon 8e, France
  • Mediso Orvosi Berendezes Fejleszto es Szerviz Kft., Budapest, Hungary
IHI industry partners
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • Boehringer Ingelheim Pharma GMBH &Co Kg, Ingelheim am Rhein, Germany
  • Charles River Laboratories France Safety Assessment, Saint-Germain-Nuelles, France
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Glaxosmithkline Research & Development Limited, Brentford, Middlesex, United Kingdom
  • H. Lundbeck As, Valby, Denmark
  • Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A., Colleretto Giacosa, Italy
  • Labcorp Early Development Laboratories Limited, Harrogate, United Kingdom
  • Merck Healthcare Kgaa, Darmstadt, Germany
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Sanofi, Bridgewater, United States
  • Sanofi-Aventis Deutschland GMBH, Frankfurt / Main, Germany
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
Contributing partners
  • Breakthrough T1d, New York, United States
  • Verisim Life Inc, San Francisco, United States

Participants
NameEU funding in €
Aarhus Universitet768 438
Avantea SRL200 625
Biotalentum Tudasfejleszto Kft948 541
Ellegaard Gottingen Minipigs As284 825
Etisense551 459
Karolinska Institutet374 479
Katholieke Universiteit Leuven599 985
Ludwig-Maximilians-Universitaet Muenchen1 039 604
Mediso Orvosi Berendezes Fejleszto es Szerviz Kft.197 500
Technische Universitaet Muenchen1 900 375
Universiteit Antwerpen784 650
Ustav Zivocisne Fyziologie A Genetiky Av Cr V.V.I.149 854
Veterinaermedizinische Universitaet Wien699 221
Total Cost8 499 556