A-TANGO has received about €6 million EU-funding to proof effectiveness and safety of G-TAK – an innovative, novel treatment strategy that combines granulocyte-colony stimulating factor (G-CSF) and TAK-242, an inhibitor of Toll-like receptor-4 (TLR-4). Pre-clinical studies in rodent models of liver failure indicate an extremely high treatment efficacy for G-TAK, while clinical studies to determine the dosage, safety, tolerability, pharmacokinetics (how the body processes a drug), and pharmacodynamics (how a drug affects the body) of each of the two molecules by itself have already been completed. A-TANGO now takes it to the next level by testing this novel combinatorial treatment, G-TAK, in a large, randomized, controlled phase II clinical trial to determine its efficacy in patients with alcohol-related hepatitis and ACLF across Europe.
A-TANGO aims to provide proof of concept data of G-TAK in ACLF patients that would allow initiation of late-phase clinical trials to improve the survival rate, treatment outcome, and quality of life for patients with alcohol-related hepatitis and ACLF. A-TANGO will also expand the scientific understanding of the underlying pathophysiological mechanisms that lead to decompensated cirrhosis, alcohol-related hepatitis, and ACLF. A-TANGO also aims to identify biomarkers for better patient stratification, which may improve overall treatment outcome.
If G-TAK proves to be efficient, conservative predictions indicate that A-TANGO has the potential to increase the survival rate of ACLF patients by 20%. This would imply approximately 12,000 fewer patients on the waiting list for a liver transplant in Europe per year, about €60,000 savings per patient, and up to €720 million savings with regard to healthcare costs in Europe each year. Another key goal of A-TANGO is increasing societal awareness, reducing stigmatization and deepening scientific literacy regarding chronic liver disease.
Prof. Rajiv Jalan MD, PhD, is the Scientific Director of EF CLIF, the Head of the Liver Failure Group at University College London (UCL), and serves as Coordinator of A-TANGO. Hepatologist Dr. med. Cornelius Engelmann at Charité – Universitätsmedizin Berlin spearheads the clinical trial as Principal Investigator. The A-TANGO Consortium consists of 14 institutions, including five university hospitals, six small and medium-sized enterprises (SMEs), including Hepyx Ltd. (which owns background intellectual property), the European Association for the Study of the Liver (EASL) and the European Liver Patients Association (ELPA). Prof. Rajiv Jalan, Dr. med. Cornelius Engelmann, and Dr. Fausto Andreola together with colleagues from UCL invented the novel combinatorial therapy G-TAK, which will be tested at 30 clinical sites across Europe.
This study received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 945096.
European Foundation for the Study of
Chronic Liver Failure
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© European Foundation for the Study of Chronic Liver Failure 2024
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