Investors have gone with their gut on EnteroBiotix’s microbiome-based lead therapy, EBX-102-02, pledging £19m ($25m) to fund a mid-stage trial of the drug in irritable bowel syndrome (IBS).
The financing, which was led by Thairm Bio and the Scottish National Investment Bank, will primarily go towards the initiation of a Phase IIb study on EBX-102-02 in patients with moderate-to-severe IBS with constipation (IBS-C), which EnteroBiotix’s CEO, Dr James McIlroy, tells Clinical Trials Arena will be the largest microbiome trial in this indication to date.
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During the study, the company will enrol around 300 patients across the UK with constipation-predominant IBS. They will be randomised to receive either two doses of the drug or a placebo, with patients being assessed in a follow-up for 12 weeks after the second dose. EnteroBiotix will dose the first patients in this study “within the next two months”, with topline efficacy data expected in H2 2027.
The rest of the funds will be used to support EBX-102-02’s Phase III readiness, with the biotech specifically focusing on the formulation, analytical methods and the supply chain, McIlroy says. EnteroBiotix aims to be ready to begin global Phase III registrational trials in 2028, provided the Phase IIb trial generates an efficacy signal.
EBX-102-02 is a microbiome-based oral therapy containing more than 400 species of gut bacteria, which are designed to form colonies in the small intestine to help address the microbiome imbalance seen in IBS patients. EnteroBiotix uses dormant microorganisms derived from vetted healthy donor samples to produce EBX-102-02, which are pooled together to ensure consistency across batches.
Addressing unmet needs in IBS
EnteroBiotix’s efforts come as the International Foundation for Gastrointestinal Disorder (IFFGD) estimates that between five and 10% of the global population have IBS, with a survey conducted by the organisation finding that 68.6% of participants had moderate-to-severe disease.
Despite the high prevalence of IBS, there are limited therapeutic options for patients, with the approved pharmaceutical choices specifically focused on stimulating bowel movements – a method McIlroy says shows modest efficacy.
“When you look a drug versus placebo responses in pivotal studies for approved IBS therapies, you typically see a 10-15% improvement,” he explains. “They also have no disease-modifying impact, and they tend to come with significant limitations like severe diarrhoea,” McIlroy adds.
This is where EBX-102-02 could show a unique benefit, as the drug is engineered to address a patient’s microbiome balance – offering a potentially disease-modifying treatment for this patient group.
EBX-102-02’s is also differentiated from the IBS-focused precision probiotics sold by supplement companies, McIlroy adds, as the drug contains a far greater number and diversity of bacterial species and is dosed less frequently than daily supplement products.
“Instead of delivering a singular or a small number of bugs with one mechanism of action, EBX-102-02 acts through a multimodal approach, as it contains a broad diversity of microorganisms with different phenotypic properties,” McIlroy notes.
This means that the drug can potentially target different aspects of IBS pathophysiology simultaneously, he says.
If EBX-102-02 reaches the IBS patient population, EnteroBiotix plans to pursue partnerships to commercialise the drug. McIlroy predicts that physicians will prescribe the drug in the second like plus prescription setting.
McIlroy adds that, if the company generates compelling efficacy data in Phase IIb, it could unlock “additional routes of capital and partner interest” to explore further avenues for microbiome-based drugs in other indications outside of IBS.
