Project description
A mouse model for drug toxicology studies
Nearly 7 in 10 drugs under development fail due to toxicity or issues in metabolism and excretion. Current drug testing models do not faithfully recapitulate human liver physiology and are thus unsuitable for predicting the safety of drugs destined for human use. To address this problem, the EU-funded His-Li mouse project is developing a humanised mouse model that is suitable for preclinical drug testing. The His-Li mouse offers humanised liver and immune system function, allowing for more faithful results regarding drug safety. Following the feasibility study, the project will formulate a marking and supply strategy to introduce the His-Li mouse model into the pharmaceutical industry.
Objective
Preclinical toxicology evaluation is the most critical step in pharmaceutical drug development, representing about 21.2% of the total drug development costs. About 70% of drug development programs fail due to toxicity or unexpected issues in Absorption, Distribution, Metabolism, and Excretion (ADME) at Phase 1 validation on humans. The main problem lies on the lack of accurate and reliable pre-clinical mouse models: in fact, current models fail to reflect human liver physiology, and often lead to the development of drugs that are safe in mice, and reveal unpredictably toxic or even deadly in humans. Strikingly, only 13.8% of drugs development programs are finally approved. The development of a single drug requires at least 1,000 iterations, accounting for about €10 M in total, and procedures that can take up to 10 years.
TransCure bioServices offers the His-Li-mouse, a humanized mouse model for pre-clinical drug testing, based on the unique combination of the humanized liver and immune systems. His-Li-mouse is the first pre-clinical model that perfectly reflects the human liver physiology and immune response, thus representing a unique tool to perform reliable pre-clinical safety and efficacy tests of drugs. His-Li-mouse enables to reduce the failure rate observed when reaching the clinical trials and to subsequently eliminate unnecessary and costly experimental iterations. This will benefit to the global population, as a more efficient drug development process will potentially save millions of lives or improve its quality by enabling the faster discovery of breakthrough pharmaceuticals.
During the phase 1 feasibility study, TransCure will establish a sound go-to-market strategy and supply chain, and will draft further development plans. During the innovation project, TransCure will optimise the humanization protocol, scale-up mice generation and validate the His-Li-mouse pre-clinical service with prospect customers.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- medical and health sciencesclinical medicinegastroenterologyinflammatory bowel disease
- medical and health sciencesbasic medicineimmunology
- medical and health scienceshealth sciencesinfectious diseasesRNA virusescoronaviruses
- medical and health sciencesclinical medicinecardiologycardiovascular diseases
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Programme(s)
Call for proposal
(opens in new window) H2020-EIC-SMEInst-2018-2020
See other projects for this callSub call
H2020-SMEInst-2018-2020-1
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
74160 ARACHAMPS
France
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.