"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
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