EnteroBiotix Limited, a clinical stage biotechnology company focused on developing best-in-class full-spectrum microbiome therapeutics, today announced the initiation of a multi-centre randomised double-blind placebo controlled Phase 2 clinical trial.
The trial has been designed to evaluate EBX-102, the company’s lead product candidate, for the treatment of liver cirrhosis and hepatic encephalopathy.
Hepatic encephalopathy is a debilitating and recurring condition that causes neuropsychiatric conditions because of liver failure. It is a common complication of cirrhosis with an associated twelve month mortality rate of up to 40% of affected patients. Symptoms may include movement problems, and changes in mood or personality. In the advanced stages it can result in a coma. The underlying mechanism is believed to involve the build-up of microbiome derived toxins, such as ammonia, in the blood.
EBX-102 is presented in the form of an orally administered capsule that contains diverse full-spectrum microbial ecosystems that are intended to restore microbial ecology and act in concert to target multiple key disease pathways.
The Phase II study, named ‘IMPuLCE’ (Intestinal Microbiota Product in Liver Cirrhosis and Encephalopathy) intends to enrol 56 patients with liver cirrhosis across sites in the United Kingdom. The trial evaluates EBX-102 in patients with cirrhosis and HE being treated with standard of care medications, including Rifaximin.
Dr James McIlroy, Founder and CEO of EnteroBiotix, said: “EnteroBiotix’s singular focus is to develop products that contain all the beneficial elements of a heathy microbiome in the form of a dried, colourless, odourless free flowing powder. 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”.
Ewan Forrest, Consultant Hepatologist at Glasgow Royal Infirmary and Honorary Professor at the University of Glasgow, and principal investigator for the IMPuLCE trial, said: “Hepatic encephalopathy 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. 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. We are delighted to be partnering with EnteroBiotix to use its product to modulate the gut microbiome in these patients with the aim of breaking this cycle and preventing hospitalisations and in some cases, death. We are entering a new era for microbe-based medicines.”
EnteroBiotix’s products have potential applicability across multiple disease areas including immuno-oncology and auto-immunity. The Company’s manufacturing capabilities include its novel proprietary AMPLA™ platform that enables the creation of full-spectrum and defined microbiome therapeutics that maintain viability at room temperature without the need for lyophilization.
