The Consortium is developing and testing Carbalive™, an orally administered, non-absorbable engineered carbon of controlled porosity. The microscopic design of the Carbalive™ beads emerged from research into the importance of gut bacteria in the inflammation that accompanies cirrhosis. The research into the effects of the leakage of bacteria and bacterial products from the gut to the rest of the body, and how to inhibit it, was led by Prof. Rajiv Jalan, Dr. Jane Macnaughtan and members of the Liver Failure Group at University College London, and Yaqrit Ltd. was spun off from UCL in 2014 to develop and potentially commercialize treatments including Carbalive™ for patients with chronic liver disease. 

Carbalive™ 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 hospitalization, is characterized pathophysiologically by systemic inflammation and carries a high risk of short-term mortality. 

The randomized 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 alcohol-related cirrhosis who had been abstinent from alcohol for the previous four weeks. 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 bacterial translocation (i.e., less leakiness of the gut wall) and improvement of gut microbiota; 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.

Professor Rajiv Jalan, Professor of Hepatology at UCL, Scientific Director of EF 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 Ltd. 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.”

Yaqrit Ltd., the Carbalive™ intellectual property and commercial rights holder intends to conduct a randomized placebo-controlled pivotal trial beginning in 2021 across Europe. The Company plans to pursue investigation of Carbalive™ in further indications and to engage consultants in 2021 to advise as to the potential regulatory pathway in the US. Full results from the trial will also be submitted for peer reviewed publication in a leading scientific journal.