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Diagnosis and Exclusion of Drug-Induced Liver Injury by using Patient Blood Samples (DILITEST)

Objective

Ca. 1 billion USD are lost by late stage failures per one successfully marketed drug. Idiosyncratic Drug induced Liver injury (iDILI) is one of the major causes for late stage failures and also can have serious consequences for the patient like death or the need for liver transplantation. iDILI occurs only in susceptible patients regardless of drug dosage or latency and is not predictable from preclinical in vitro or animal testing. Usually it occurs during late stage clinical phases, when hundreds of millions of USD were already invested in the drug. Therefore, iDILI is a significant challenge for patients, drug-developers and regulatory bodies. Until now there is no valid test available that allows to positively diagnose or exclude a drug as iDILI cause, resulting in incorrect market withdrawals or project terminations. Since the majority of patients would tolerate the drug, these patients are deprived from innovative treatment options. DILITEST aims to develop a test to diagnose iDILI in individual patients and identify the causaltive drug. The test is based on a patented method to generate liver cell-like cells from a blood sample. This will allow to prevent investment losses by incorrect market withdrawals or terminations and solve the dilemma of iDILI for patients, pharmaceutical industry and regulatory bodies by enabling marketing of safe drugs and avoiding incorrect terminations. Overall objective of DILITEST is to market the highly innovative test by MetaHeps GmbH after validation in independent cohorts of european and american registries led by international experts in the field of iDILI research.
MetaHeps GmbH will provide the unrivaled technology as a service to pharmaceutical industry with focus on the still growing high volume clinical trial market, allowing its customers to prevent late stage failures by either excluding the drug as a cause for iDILI or the possibility to make use of the novel test to identify novel saftey biomarkers.

Fields of science (EuroSciVoc)

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

SME-1 - SME instrument phase 1

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-SMEInst-2014-2015

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Coordinator

METAHEPS GMBH
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 50 000,00
Address
AM KLOPFERSPITZ 19
82152 Planegg
Germany

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Bayern Oberbayern München, Landkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 71 429,00
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