EnteroBiotix Initiates Phase 2 Study of EBX-102-02 in Patients with Irritable Bowel Syndrome (IBS)

2024-04-03

临床2期微生物疗法

GLASGOW, Scotland, April 03, 2024 (GLOBE NEWSWIRE) -- EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today 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 IBS. 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 AMPLATM technology and is manufactured from its GMP-certified manufacturing facilities in Scotland. 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. 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.” About Irritable Bowel Syndrome (IBS) 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. TrIuMPH Study Contacts: EnteroBiotix Dr James McIlroy CEO at EnteroBiotix j.mcilroy@enterobiotix.com Scius Communications Katja Stout +447789435990 katja@sciuscommunications.com Daniel Gooch +447747875479 daniel@sciuscommunications.com About EnteroBiotix EnteroBiotix is a clinical-stage biopharmaceutical company developing best-in-class full-spectrum microbial therapeutics for patients with serious unmet medical needs. The Company is leveraging its product platform to address patient needs through a pipeline of tailored high-diversity products that fortify and restore the microbiome. EnteroBiotix has a strategic partnership with Imperial College London to enable clinical trials in high-unmet need clinical indications and recently announced the initiation of a Phase 2 clinical trial in IBS. The Company has completed patient enrolment in a Phase 2 clinical study in liver cirrhosis. EnteroBiotix has differentiated platform manufacturing technologies and a well-developed analytical toolkit that confers superior product characteristics. The Company operates sophisticated MHRA licensed manufacturing infrastructure, together with its Number 2® brand, which ensures the safety, security, quality, and sufficiency of supply of microbiota obtained from healthy human donors. Established in 2017, EnteroBiotix is headquartered in Glasgow, Scotland, and operates research laboratories and MHRA licensed GMP pharmaceutical manufacturing sites in Glasgow and Aberdeen. The Company’s investors include Thairm Bio, Kineticos Life Sciences, and Scottish Enterprise Growth Equity. For more details see and About The 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. Established in 2013, FGC has an extensive R&D and Clinical trials portfolio helping to design and test future digestive health tests and treatments. For more details see