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

Periodic Reporting for period 1 - DILITEST (Diagnosis and Exclusion of Drug-Induced Liver Injury by using Patient Blood Samples(DILITEST))

Reporting period: 2015-12-01 to 2016-04-30

"Drug-induced liver injury (DILI) is the main cause for acute liver failure and an important reason for regulatory actions on drugs. Idiosyncratic DILI (iDILI) affects only susceptible patients and is not predictable from animal or in vitro models. Thus, iDILI cases in drug-development often occur late in the development process (e.g. Phase 3 or post-marketing), leading to late stage drug failures or market withdrawals. Due to the potentially lethal outcome a few iDILI cases in a late stage trial might be sufficient to terminate the project.
One of the major issues of iDILI is its extremely difficult diagnosis, relying on exclusion of other causes for liver damage and expert opinion as golden standard. However, especially in polymedicated patients, it might be inpossible to assess the causality of a single drug. This might lead to a relevant number of ""false positive"" iDILI cases threatening drug developers and depriving patients from urgently needed novel therapies.
Thus, there is an urgent need for an unbiased method to diagnose and/or exclude iDILI in individual cases as well as identifying the causative agent to better assess the risk of novel medicines. Furthermore, improved case definition (and drug causality) may lead to the development of novel biomarkers for iDILI by elimination false positives from the test cohortts.
MetaHeps GmbH has developed an innovative test that allows diagnosis and/or exclusion of iDILI in individual patients by means of a blood sample (MetaHeps test). MetaHeps GmbH aims to demonstrate the use of MetaHeps® test as a world-wide novel and unbiased in vitro diagnostic tool for iDILI linked to a pertinent clinical endpoint.
Objectives of the Phase 1 project is a feasibility study for the use of the test in pharmacovigilance and drug development with pharceutical companies and contract research organisations (CROs) as customers and partners.
The MetaHeps® test will allow to reduce incorrect project terminations, better risk assessment of innovative drugs and the development of novel biomarkers to increase drug safety as well as productivity of drug-development by offering novel insights in individual iDILI causality
Presentation at the Munich Biomarker Conference 2015 at Dec 1st 2015
Presentation at the Personalised Medicine and Biomarkers 2015 Conference Dec 2nd and 3rd 2015 in London
Presentation at DIA-Congress Europe 2016 in Hamburg Germany
Poster presentation at International Liver Congress, Barcelona, Spain April 14th, 2016
Invited AASLD webinar June 30th2016

Ongoing contact with regulatory agencies aiming at validation of the test
Contacts with customers and partners
In the feasibility study a market study was performed which shows that the challanges of iDILI in drug-development are still present and not much progress was made in terms of liver saftey in the last 30 years. A FTO analysis was obtained showing that complete freedom to operate exists and contacts to important key opinion leaders in academia and industry could be established and deepened. Furthermore, first contacts to the regulatory authorities resulted in positive feedback. Connections to important research networks were establieshed.
A validation study is planned.

Market study
FTO Analysis
Business plan
Cooperation initiated with international research organisations and cutomers of the technology
Scientific evidence of the technology as a novel method of causality assessment
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