• MetaHeps GmbH
  • Am Klopferspitz 19
  • 82152 Planegg/Martinsried
  • Germany
  • Phone: +49 (0)89/70076614
  • moc.spehatem@nejioorvl

MetaHeps® has developed an ex-vivo blood test to clearly identify the cause of drug-induced liver injury (DILI) in a suspected individual patient. MetaHeps® was founded in 2014 by leading hepatology experts as a spin-off from the university hospital Grosshadern der LMU, Munich, Germany. It has a strong IP position in the US, EU and in Japan. The vision of MetaHeps® is to increase access of patients to novel and existing drugs by quickly solving and preventing DILI issues in an unrivaled and innovative approach.

Idiosyncratic DILI is an important reason for acute liver failure and also a huge risk for marketed drugs and drugs in clinical development: iDILI affect only few patients (e.g. 1 in 10.000) while most of patients can be treated without developing liver damage. There is no clear dose-relationship and the latency of iDILI varies between weeks and months. The importance of the individual patient characteristics for the occurrence of iDILI precludes detection in preclinical (cell or animal) models. Therefore, iDILI is often only detected in late stage clinical trials potentially leading to project terminations or even market withdrawals with huge financial losses. There is also relevant damage to patients: the susceptible patients, which potentially develop life-threatening liver failure, but also the other patients, which tolerate the drug, may lose an important treatment option because of market withdrawals or study terminations.

 

iDILI diagnosis is mainly based on exclusion of other etiologies of liver damage (e.g. viral hepatitis) and gold standard for causality assessment is expert opinion. In patients taking several drugs it may be impossible to identify the causative agent.

 

The MetaHeps® test is offered as a service for BioPharma companies and CROs: Using a blood sample from patients with iDILI suspicion the test can

a) clear a drug from iDILI suspicion

b) identify potentially dangerous drug interactions that can be avoided in future

c) identify true positive cases for a given drug and thus facilitate the development of innovative and specific safety biomarkers.

This will improve patient safety as well as reduce incorrect stops in drug development.

 

MetaHeps GmbH is a spin-off company of the LMU Munich.