The challenge of idiosyncratic DILI
Idiosyncratic DILI is a major issue in late stage drug development
- DILI is a rare event:
- it affects only susceptible patients due to their individual characteristics, it can not be predicted
- it becomes evident when an increasing number of individuals is treated
- DILI is difficult to diagnose and drug causality may impossible to determine in patients taking several drugs
- diagnosis of exclusion & impossible causality in polymedication ► no possibility to clear DILI suspicion from a drug
- failure to correctly diagnose DILI or adjudicate causality ► lack of biomarkers to rescue a drug with DILI issues
MetaHeps® testing of your study participants/patients is possible up to 6 months after DILI onset
We recommend MetaHeps® testing as a part of clinical trial protocols:
- immediate MetaHeps® testing in case of DILI suspicion
- charges apply only in case our services are requested
These cells show donor specific characteristics and allow patient centric individualised toxicity testing. The generation process is standardised, without genetic modifications and under serum-free conditions. All that is required is a patient's blood sample (whole EDTA-blood). This allows testing in all patient groups (including children).
This unique technology for individualized patient testing is only necessary in cases of iDILI-suspicion. Samples of tolerators or healthy donors can be used to refine the system and ensure the patients individual susceptibility.
In case of DILI suspicion MetaHeps GmbH assists you in answering two vital questions:
- Is DILI really the cause for the observed liver damage?
- In case of DILI, which drug has caused liver injury?
What important information can MetaHeps® testing provide to you?
|Scenario 1||It is not DILI.||►It’s safe to proceed with the clinical drug development. Regulatory endorsement.|
|Szenario 2a||Another drug than the study drug has caused the liver damage.||►It’s safe to proceed with the clinical drug development. Regulatory endorsement.|
|Szenario 2b||The combination of another drug X and the study drug has caused the liver damage (drug-drug interaction).||►The study drug will obtain market approval if not taken together with drug X.|
|Szenario 3||The study drug has caused the liver damage.||►Development of DILI biomarkers together with MetaHeps GmbH for identification of patients at risk.|