Clinical trial involves patients with liver cirrhosis and hepatic encephalopathy
EnteroBiotix Limited – a company concentrating on microbiome therapeutics – has announced the commencement of a multi-centre, placebo-controlled, phase 2 clinical trial.
The study has been designed to evaluate the company’s EBX-102 candidate for the treatment of liver cirrhosis and hepatic encephalopathy (HE).
The therapy involves an orally administered capsule that contains diverse full-spectrum microbial ecosystems. This aims to restore microbial ecology and target multiple key disease pathways.
IMPuLCE – Intestinal Microbiota Product in Liver Cirrhosis and Encephalopathy – intends to enrol 56 patients with liver cirrhosis throughout sites in the UK. The research will evaluate EBX-102 among patients with HE and cirrhosis being treated with standard of care medications, including Rifaximin.
Ewan Forrest, consultant hepatologist at Glasgow Royal Infirmary and principal investigator for the IMPuLCE trial, explained: “HE is driven by reduced liver function, shunting of blood away from the liver and reduced gut epithelial integrity. This leads to increasing levels of toxins and inflammation which cause brain dysfunction.”
He added: “It is a common complication of advanced liver disease which can have a devastating impact upon quality of life. Clinical studies have shown that modulating the patient’s gut microbiome can be an effective treatment.”
Dr James McIlroy, founder and chief executive officer of EnteroBiotix, reflected: “Our product is designed to treat diseases by enhancing gut microbial ecological diversity and decolonising pro-inflammatory organisms. Initiating this study is an important milestone for both EnteroBiotix and future patients as we advance a new class of drug through the clinic, taking a step closer to realising our vision of tackling poorly or unmet clinical needs with a best-in-class full-spectrum microbiome medicine”.
HE is a recurring condition that causes neuropsychiatric conditions because of liver failure. Symptoms may include movement problems and changes in mood while, in its advanced stages, can result in a coma.