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10/02/2021

CARBALIVE announces positive results of their trial for a novel treatment for cirrhosis

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10/02/2021

This European consortium, led by the University College of London and funded by the European Union's Horizon 2020 research and innovation program, involves researchers from the Liver Diseases group at the VHIR.

The CARBALIVE Consortium has announced positive data from the Phase 2 equivalent randomised, double-blind clinical trial of Carbalive&trade,, a product candidate for the treatment of patients with decompensated cirrhosis. Carbalive&trade, is specifically designed to remove harmful bacterial toxins from the gut, reduce gut inflammation and its permeability, preventing them from leaking into the rest of the body. It is an orally-administered, non-absorbable engineered carbon of controlled porosity. The research is led by Professor Rajiv Jalan, Dr Jane Macnaughtan and members of the Liver Failure Group at University College London (UCL). Moreover, Yaqrit and the European Foundation for the Study of Chronic Liver Failure (http://www.efclif.com/ www.efclif.com), among others, also participate. This academic-industrial consortium is funded by the European Union's Horizon 2020 research and innovation programme.Carbalive&trade, has a special physical structure that adsorbs both large and small molecules in the gut. It is intended to treat patients with cirrhosis, a condition with over 100 million cases globally in 2017, accounting for the mortality of about 1 million patients each year. Patients with stable (compensated) cirrhosis from any cause, including alcohol, viral infection and fatty liver, can decompensate without warning, an event that usually leads to hospitalisation, is characterised pathophysiologically by systemic inflammation and carries a high risk of short-term mortality.Carbalive has the collaboration of two members from the Hepatology Service at Vall d'Hebron and researchers at the Liver Diseases group at the Vall d'Hebron Institute of Research (VHIR), Dr. Víctor Vargas and Dr. César Jiménez, which participated in the creation and clinical protocol consensus, patient inclusion and evaluation of results. "The advantage of this new carbon is that, when it reaches the gut, it makes possible toxic substances, involved in the inflammation that causes a worsening of liver function in patients with cirrhosis, not be absorbed, thus achieving less liver and systemic inflammation", explains Dr. Víctor Vargas.Professor Rajiv Jalan M.D., Professor of Hepatology at UCL, Founding Member of EASL CLIF and Project Coordinator for the CARBALIVE consortium, said,"With no specifically approved therapies for decompensated cirrhosis, there is a huge need for new treatment options. Results from this trial are very promising. The product's safety and tolerability profile and, preliminary efficacy data continue to give us confidence that Carbalive is a promising candidate for the treatment of liver disease."Professor Agustin Albillos M.D., of the Hospital Universitario Ramón y Cajal, Universidad de Alcalá, leader of the Liver and Digestive Diseases Group at the Ramón y Cajal Institute for Health Research-IRYCIS (Area 3) in Spain, said: "At its heart, this world leading consortium of experienced and expert research groups within the field of liver disease has sought to find a way to address the relationship between the gut's microbiome and the progression of liver injury to advanced stages and complications of cirrhosis. These results reported today indicate that Carbalive is having a positive impact on inflammation and therefore could prevent this progression of cirrhosis complications. On behalf of the Consortium, I'd like to extend our gratitude to the EU's Horizon 2020 programme, which has enabled us to bring this exciting new therapy to liver disease patients, who have few treatment alternatives."

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