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).
Non-human primates in research: an ethical issue
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 new IHI project 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.
“An exceptionally complex challenge” which can only be achieved through partnerships
“Finding alternatives to non-human primates in non-clinical research is an exceptionally complex challenge, and it’s not something any of us can tackle alone,” said project leader Majken Dalgaard of Novo Nordisk. “I am deeply committed to this important task, which can only be achieved through robust partnerships.”
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.
Project coordinator Eckhard Wolf of Ludwig-Maximilians-Universität München said: “By collaborating across public and private organisations, we aim to drive scientific innovation and develop new methodologies that will bring us closer to our ultimate goal of replacing non-human primates in our research.”