EnteroBiotix cues up larger trial of microbiome IBS therapy

UK biotech EnteroBiotix has reported proof-of-concept data for its therapy for irritable bowel syndrome (IBS) based on gut microorganism species collected from healthy, screened donors.

The Glasgow, Scotland-based company said this morning that its EBX-102-02 candidate showed "clinically meaningful" improvements on placebo in key efficacy assessments in patients with moderate to severe IBS with constipation (IBS-C) in the phase 2a TriuMPH trial.

The study also includes a cohort of patients with IBS associated with diarrhoea (IBS-D), although results from that aren't expected until later this year. Nevertheless, it intends to start a larger phase 2b trial of EBX-102-02 to further probe the efficacy of the microbiome therapy.

There has been an upsurge of interest in harnessing the gut microbiome – the bacteria, fungi, and other microorganisms that live in a healthy digestive tract – to alleviate various human health conditions.

EnteroBiotix's IBS trial is the company's second to suggest there is value in the approach, coming a few months after the phase 1b IMPuLCE trial of its EBX-102 candidate showed that it was able to reduce inflammatory biomarkers in adults with liver cirrhosis.

In TriuMPH, patients receiving eight capsules of EBX-102-02 over a seven-day period saw improvements across various efficacy measurements – including IBS Symptom Severity Score (IBS-SSS), stool consistency, average weekly complete bowel movements, and abdominal pain – compared to those receiving a matched placebo.

The results also showed that their intestinal microbiota composition became more similar to the composition of EBX-102-02, a change which was associated only with transient gastrointestinal side effects, including mild diarrhoea.

IBS is a common and sometimes lifelong bowel condition, causing symptoms such as abdominal pain and bloating as well as diarrhoea or constipation, and places a sizeable burden on the NHS as it has been estimated that somewhere between 5% and 20% of the UK population is affected. However, as many people with symptoms do not seek medical advice that could be an underestimate.

At the moment, IBS management is limited to dietary and lifestyle advice and medicines to help control symptoms, like loperamide for diarrhoea or laxatives for constipation.

Commenting on the new EBX-102-02 data, Prof Yan Yiannakou, a gastroenterologist and IBS specialist working at County Durham and Darlington NHS Foundation Trust, said that it provides evidence that microbiome therapy could become a viable treatment for IBS.

"The clinically meaningful improvements in IBS symptom severity, stool consistency and abdominal pain observed in this trial are extremely promising," he added. "There is a clear and urgent need for innovation in this space, and I look forward to supporting the continued development of this promising therapy, which could be transformational for IBS patients."