Simvastatin and Rifaximin as new therapy for patients with decompensated cirrhosis
Financing: This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 731875
Duration: January 2017 – December 2021
LIVERHOPE brings together 16 partners from 7 different European countries with industrial and academic background. The academic partners contribute by their well-recognized expertise in: hepatology; patient care; designing and leading mono-/multicentre trials; development, validation, and performance of advanced biomarker programs.
- Hospital Clinic de Barcelona, Institut de Investigacions Biomediques August Pi i Sunyer (IDIBAPS) (Coordinator), ES
- Hôpital Beaujon, FR
- University College London, UK
- Universitätsklinikum Bonn,bGE
- Università degli Studi di Padova, IT
- AOU Citta della salute e della scienza di Torino, IT
- Alma Mater Studiorm - University of Bologna, IT
- Hospital Universitari Vall d’Hebron, ES
- Academisch Medisch Centrum Amsterdam, NL
Improving the survival of patients and their quality of life is the primary objective of the LIVERHOPE project. At this aim the support and involvement of ELPA (European Liver Patients Organisation, BE) will be crucial.
The industrial partners will contribute to the project success with their documented expertise in: pharmaceutical and clinical research, drug discovery, preclinical and clinical development and systems biology solutions.
- ECRIN - European Clinical Research Infrastructure Network, FR
- Anaxomics Biotech S.L., ES
- ALFA WASSERMANN SPA, IT
- EF-CLIF, European Foundation For The Study Of Chronic Liver Failure, ES
- ALTA Ricerca e Sviluppo in Biotecnologie Srlu, IT
LIVERHOPE is committed to evaluate the efficacy of treatment with the combination of rifaximin, an antibiotic that modulates the intestinal microbiome, and statins in patients with advanced cirrhosis. The project will also focus on the search for biomarkers of the disease. The project will also focus on the search for biomarkers of the disease.
There is an unmet need for objective and specific biomarkers for assessment of clinically-important end-points, particularly for acute on chronic liver failure and survival. The goal of using a systems biology approach in the clinical trials is to make the predictive and personalized medicine a reality in the patient care. LIVERHOPE will take advantage of the data compiled in the proposed clinical trials to further explore previously identified biomarkers of cirrhosis progression and identify new prognostic biomarkers (markers able to predict the evolution of the disease) and predictive biomarkers (markers able to predict the response to the drug combination treatment) to benefit further implementation of the therapy.
The analysis of the clinical trial results with Anaxomics’ systems biology approach will complement the conventional statistical analysis through individually modelling the patients and then segmenting them according to qualitative or quantitative characteristics that are somehow related to the molecular mechanism of the treatment under study. Anaxomics will identify certain measurable traits (biomarkers) that are specifically associated with the therapeutic response to the drug in different population subsets. The biomarkers identified in this manner are, therefore, mechanistic biomarkers, i.e. molecules that are rooted in the disease pathogenesis. These biomarkers have been claimed to be superior to descriptive biomarkers for a number of reasons: they are more likely to be specific to the disease, they enable differentiation of distinct subtypes of the same disease, allowing for target treatment, and they can reveal if the therapy is efficacious at targeting the cause of a disease, rather than simply improving the symptoms.