TrIuMPH: Investigational agent for IBS plus constipation shows potential

EBX-102-02 displayed promising safety and efficacy data for patients with irritable bowel syndrome (IBS) and constipation in a phase 2 study, supporting further evaluation of this agent in a larger patient population.

The phase 2 TrIuMPH trial (ISRCTN65517362) studied the investigational agent EBX-102-02, a next-generation oral full-spectrum microbiome drug, in patients with IBS with constipation. Participants (n=62) had an IBS symptom severity scale (SSS) score of at least 175 and were randomised 2:1 to the investigational agent or a placebo. Prof. Anthony Hobson (Functional Gut Clinic, UK) and colleagues looked at safety, tolerability, effects on daily bowel habits, and quality-of-life [1].

Prof. Hobson mentioned that the experimental drug was generally well-tolerated. “We observed only 1 treatment-emergent adverse event that led to study discontinuation, being a case of vomiting,” he said. The most common adverse events were mild, self-limiting, and of gastrointestinal origin. From baseline to week 3, the IBS-SSS score had dropped 68 points in the active treatment arm and 34 points in the placebo arm. From baseline to week 7, the respective reductions were 78 points and 53 points. Finally, abdominal pain, measured by IBS-SSS, was reduced by 14.1 points in the EBX-102-02 arm and by 9.3 points in the placebo arm.

“EBX-102-02 had an acceptable safety profile in this population of patients with IBS and constipation,” concluded Prof. Hobson. “Furthermore, patients treated with this product had larger improvements in IBS-SSS scores, abdominal pain, and stool consistency than patients in the placebo group.”

1. Craven LJ, et al. A randomised, double-blind, placebo-controlled, phase II trial assessing the safety and efficacy of EBX-102-02, an oral full-spectrum intestinal microbiota product, in patients with irritable bowel syndrome with constipation; the TRIUMPH trial. Abstract Mo1342, Digestive Disease Week 2025, 3–6 May 2025, San Diego, USA.

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Posted on 21 May 202521 May 2025