LIVERHOPE · Project

Repurposed Drug Combination to Treat Advanced Liver Cirrhosis and Cut Hospital Costs

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liverhopeh2020.eu

Liver cirrhosis kills hundreds of thousands of Europeans, and doctors have been stuck treating symptoms with essentially the same playbook for 20 years. LIVERHOPE took two existing, well-known drugs — a cholesterol pill (simvastatin) and a gut antibiotic (rifaximin) — and tested whether combining them could actually slow the disease instead of just managing its fallout. They ran two rigorous clinical trials across five countries with 285 patients to see if this combo could keep patients out of the hospital and alive longer. Think of it like discovering that two common over-the-counter medicines, used together, could tackle a disease that had no real treatment before.

By the numbers

285

patients enrolled in two randomized double-blind clinical trials

EU countries where trials were conducted (DE, ES, FR, IT, UK)

20 years

since treatment of cirrhosis has substantially changed

EUR 5,998,800

EU contribution to fund clinical trials and research

consortium partners across 8 countries

industry partners including 3 SMEs in the consortium

The business problem

What needed solving

Liver cirrhosis is one of the leading causes of death in Europe, yet treatment has not fundamentally changed in 20 years — doctors can only manage symptoms as they appear. There is no approved therapy that targets the underlying disease progression, leaving hospitals with repeated expensive admissions and patients with declining quality of life. The economic burden on health systems is enormous, with no cost-effective intervention available to break the cycle of complications and readmissions.

The solution

What was built

The project completed two randomized double-blind clinical trials testing the combination of simvastatin and rifaximin in 285 patients with decompensated cirrhosis across 5 EU countries. It also identified biomarkers for treatment response and disease progression, and produced communication materials for patient associations and families.

Audience

Who needs this

Generic pharmaceutical companies seeking de-risked drug repurposing opportunities in hepatologyHospital networks and health systems looking to reduce cirrhosis readmission costsCompanion diagnostics companies developing liver disease biomarker panelsHealth insurers evaluating cost-effective interventions for chronic liver diseaseClinical research organizations specializing in gastroenterology/hepatology trials

Business applications

Who can put this to work

Pharmaceutical & Generic Drug Manufacturing

mid-size

Target: Mid-size pharma companies with hepatology or gastroenterology portfolios

If you are a pharmaceutical company looking for de-risked drug candidates in liver disease — this project ran two randomized double-blind clinical trials with 285 patients across 5 EU countries testing a combination of two already-approved drugs (simvastatin + rifaximin) for decompensated cirrhosis. Because both drugs are already generic and well-characterized, the regulatory path to market is significantly shorter and cheaper than a novel molecule. The clinical data package from this EUR 5,998,800 publicly funded program is available for licensing or partnership.

Hospital Networks & Healthcare Systems

enterprise

Target: Large hospital groups and national health services managing chronic liver disease patients

If you are a hospital network spending heavily on repeated admissions for cirrhosis complications — this project demonstrated a therapeutic strategy specifically designed to reduce hospital readmissions and prevent acute-on-chronic liver failure, the leading cause of death in these patients. The trials enrolled 285 patients across Germany, Spain, France, Italy, and the UK, generating real-world evidence on cost-effectiveness. Adopting this treatment protocol could directly cut your cirrhosis-related bed occupancy and emergency costs.

Diagnostic & Biomarker Development

SME

Target: Companies developing companion diagnostics or prognostic biomarker panels for liver disease

If you are a diagnostics company seeking validated biomarkers for liver disease progression — LIVERHOPE investigated biomarkers of treatment response and disease progression as part of their clinical trials with 285 patients. These biomarkers could be developed into companion diagnostic tests that predict which patients will benefit from the therapy or identify early signs of acute-on-chronic liver failure. The 22-partner consortium across 8 countries provides a multi-center validation dataset.

Frequently asked

Quick answers

What would it cost to license or adopt this therapy?

Both simvastatin and rifaximin are already approved generic drugs, which means manufacturing costs are low compared to novel biologics. The project invested EUR 5,998,800 in clinical validation, so any licensee would benefit from publicly funded trial data without bearing the full R&D cost. Specific licensing terms would need to be negotiated with the coordinating institution in Barcelona.

Can this scale to industrial pharmaceutical production?

Yes — both drugs are already manufactured at scale by multiple generic pharmaceutical companies worldwide. The challenge is not production but regulatory approval for the specific combination indication in decompensated cirrhosis. The clinical trial data from 285 patients across 5 EU countries provides a foundation for regulatory submissions.

What is the IP and licensing situation?

Since both simvastatin and rifaximin are off-patent generic drugs, the IP likely centers on the specific combination protocol, dosing regimen, and clinical trial data rather than compound patents. The coordinating institution (Fundació de Recerca Clínic Barcelona-IDIBAPS) would hold rights to the trial data and any method-of-treatment patents filed. Contact the coordinator to discuss licensing arrangements.

What regulatory approvals would be needed?

Both drugs are individually approved by EMA and FDA, which significantly de-risks the regulatory pathway. However, approval for the specific combination indication in decompensated cirrhosis would still require regulatory review. The two randomized double-blind trials conducted across 5 EU countries provide a strong clinical evidence package for regulatory submissions.

How long until this could reach patients commercially?

The project ran from 2017 to 2023 and completed its clinical trials. Based on available project data, the next steps would be regulatory submission for the combination indication, which could take 2-3 years depending on the jurisdiction. The fact that both drugs are already approved and well-characterized could accelerate this timeline compared to a new chemical entity.

How does this integrate with existing hospital treatment protocols?

The therapy uses two drugs that hospitals already stock and prescribe — simvastatin for cholesterol and rifaximin for hepatic encephalopathy. Integration into existing clinical workflows would be straightforward since medical staff are already familiar with both drugs, their side effects, and their management. The project specifically studied safety and tolerability in the decompensated cirrhosis population.

Consortium

Who built it

The LIVERHOPE consortium brings together 22 partners across 8 European countries (Belgium, Switzerland, Germany, Spain, France, Italy, Netherlands, UK), with a strong clinical and academic backbone of 8 universities and 7 research organizations. The 4 industry partners (including 3 SMEs) at 18% industry ratio suggest the project is research-driven rather than commercially led, which is typical for clinical trial programs at this stage. The multi-country setup was essential for recruiting 285 patients across 5 trial sites. The coordinator is Fundació de Recerca Clínic Barcelona-IDIBAPS, one of Spain's top biomedical research institutes affiliated with Hospital Clínic de Barcelona, a leading European liver disease center. For a business partner, the commercial translation will likely require a pharmaceutical company to step in for regulatory filing and market access — the consortium has generated the clinical evidence, but commercialization infrastructure is limited.

FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYERCoordinator · ES
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORKparticipant · FR
UNIVERSIDAD POMPEU FABRAparticipant · ES
UNIVERSITATSKLINIKUM BONNparticipant · DE
ANAXOMICS BIOTECH SLparticipant · ES
ASSISTANCE PUBLIQUE HOPITAUX DE PARISparticipant · FR
INNOVATION ACTA SRLparticipant · IT
UNIVERSITA DEGLI STUDI DI PADOVAparticipant · IT
STICHTING AMSTERDAM UMCparticipant · NL
JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAINparticipant · DE
Private Universitaet Witten/Herdecke gGmbHthirdparty · DE
UNIVERSITAT ZURICHparticipant · CH
AZIENDA OSPEDALIERA CITTA DELLA SALUTE E DELLA SCIENZA DI TORINOparticipant · IT
AZIENDA OSPEDALE UNIVERSITA PADOVAthirdparty · IT
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNAparticipant · IT
HOSPITAL CLINIC DE BARCELONAthirdparty · ES
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLUparticipant · IT
EUROPEAN LIVER PATIENTS ASSOCIATIONparticipant · BE
UNIVERSITY COLLEGE LONDONparticipant · UK
FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCAparticipant · ES
EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF)participant · ES

How to reach the team

Fundació de Recerca Clínic Barcelona-IDIBAPS (Spain) — a top biomedical research institute at Hospital Clínic de Barcelona. SciTransfer can facilitate an introduction to the project team.

Order a report on this consortium See FUNDACIO DE RECERCA CLINIC BARCELONA-INSTITUT D INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER profile →

Next steps

Talk to the team behind this work.

Interested in licensing the LIVERHOPE clinical trial data or exploring a commercialization partnership for this cirrhosis therapy? SciTransfer can connect you with the research team and help structure a deal. Contact us for a detailed briefing.

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