EnteroBiotix begins phase 2 study of EBX-102-02 in patients with irritable bowel syndrome

Overview

EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, announced that the first patient has been dosed in a multi-centre randomised double-blind placebo controlled clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS).

TrIuMPH Trial 

• The phase 2 study, named ‘TrIuMPH’ (treating IBS with an intestinal microbiota product for health) will initially enrol 60 patients with IBS and constipation across sites in the United Kingdom. 
• The primary objective of the study is to assess the safety and tolerability of EBX-102-02. 
• Secondary and exploratory endpoints relate to assessing preliminary signals of efficacy of EBX-102-02 and potential biomarkers over a six-week period. 
• The trial will be delivered in partnership with the Functional Gut Clinic, a leading IBS diagnosis and treatment centre. 
• EBX-102-02 utilises the company’s proprietary AMPLA technology and is manufactured from its GMP-certified manufacturing facilities in Scotland.

EBX-102-02

• EBX-102-02 is a next-generation, full-spectrum drug candidate that contains highly diverse microbial ecosystems and key functional groups that restore and fortify the microbiome. 
• EBX-102-02 is presented as an easy to take capsule containing off-white colour odourless powder.

Words from CEO: EnteroBiotix

Dr James McIlroy, CEO of EnteroBiotix, said: “We are excited to have achieved this important milestone in our quest to alleviate the suffering caused by IBS. We believe that EBX-102-02 has the potential to be transformational for the IBS patient community and for the field of microbiome therapeutics. We look forward to working in collaboration with our partners to take us closer to realising our vision of tackling unmet clinical needs with best-in-class full-spectrum microbiome medicines.”

Irritable Bowel Syndrome

• Irritable bowel syndrome (IBS) is a chronic relapsing functional GI disorder, with patients experiencing a range of symptoms, such as chronic abdominal pain, cramping, bloating and change in bowel movements – which may include constipation, diarrhoea, or both. 
• It is estimated that up to 1 in 8 people suffer from IBS type symptoms, and there is approximately an equal split between patients experiencing predominantly constipation (IBS-C) versus diarrhoea (IBS-D). 
• IBS has a very significant healthcare and economic burden.

About EnteroBiotix

EnteroBiotix is a clinical-stage biopharmaceutical company developing best-in-class full-spectrum microbial therapeutics for patients with serious unmet medical needs.

Functional Gut Clinic

• The Functional Gut Clinic (FGC) is the UK’s leading independent provider of gastrointestinal physiology testing and diagnostics. 
• FGC provides both private and NHS services around the UK and are the only independent GI physiology clinic to have IQIPS/UKAS and CQC accreditation.