The European CARBALIVE Consortium, including Dr. Albillos’ Group, announces positive results of a Phase 2 trial for a novel cirrhosis treatment

Thursday, 7 January 2021

CARBALIVE Initiative will generate impact in society since it is in the way to improve the survival of patients with cirrhosis, hopefully becoming one of the first effective intervention to treat advanced cirrhosis. The CARBALIVE approach to cirrhosis, based on gut microbiota modification is aligned with the large experience of our Institute in this field and reinforce this gamble of future at IRYCIS.

The CARBALIVE Consortium announces positive data from the Phase 2 equivalent randomised, double-blind clinical trial of Carbalive™, a product candidate for the treatment of patients with decompensated cirrhosis. Carbalive™ 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.

The CARBALIVE consortium is an academic-industrial collaboration funded by the European Union's Horizon 2020 research and innovation programme (grant agreement No 634579), focused on developing a novel treatment for patients with advanced liver disease. It is composed of partners from across Europe, led by University College London. Dr. AGUSTÍN ALBILLOS, leading the Liver and digestive diseases Group at IRYCIS, is the only Spanish partner.

The CARBALIVE consortium is an academic-industrial collaboration funded by the European Union's Horizon 2020 research and innovation programme (grant agreement No. 634579), focused on developing a novel treatment for patients with advanced liver disease. It is composed of partners from across Europe, led by University College London. Dr. AGUSTÍN ALBILLOS, leading the Liver and Digestive diseases Group at IRYCIS, is one of the Spanish partners.

The Consortium is developing and testing Carbalive™, an orally-administered, non-absorbable engineered carbon of controlled porosity. It is intended to treat patients with cirrhosis, a condition with over 100 million cases globally (1) in 2017, accounting for the mortality of about 1 million patients each year (2).

The randomised controlled, double-blinded clinical trial investigated the safety and tolerability of Carbalive™, compared to placebo, over a three-month treatment period in adults with stable decompensated cirrhosis.

Carbalive™ was found to be safe, based on detailed clinical and biochemical assessments compared with the placebo and, was well tolerated with compliance of greater than 90%. Preliminary data from the trial also showed trends in the improvements of a wide range of biomarkers of systemic inflammation, which is especially notable because Carbalive™ is not systemically absorbed. Measures of gut-specific health also improved in Carbalive™ patients compared to those on the placebo arm. These improvements were associated with trends towards reduction in the markers of gut inflammation, less translocation (leakiness) of the gut wall and improvement of gut bacterial flora; characteristic problems associated with cirrhosis and its complications. The conclusions set forth in this announcement remain subject to finalizing the remaining data analysis, the statistical and clinical study report and, therefore may change. For more information visit www.carbalive.eu and www.yaqrit.com

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. Yaqrit is now planning to proceed with a pivotal trial in Europe, which could pave the way for regulatory approval in this region. I acknowledge gratefully the support of the EU H2020 grant, the huge contribution of all my collaborators and the patients who have been instrumental in the progress the Consortium has made in allowing the development of this treatment that has the potential to save the lives of patients with cirrhosis".

Professor Agustin Albillos M.D., Chief of the Department of Gastroenterology Hospital Universitario Ramón y Cajal, Universidad de Alcalá, leader of Liver and Digestive diseases Group at 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".

(1) Sepanlou S et al. The global, regional, and national burden of cirrhosis by cause in 195 countries and territories, 1990-2017: A systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):245-266. PMID: 31981519.