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Summary   Background   ONO ‐2952 is a novel and selective inhibitor of translocator protein 18  kD a that reduces stress‐induced defecation and visceral hyperalgesia in rat models.    Aim  To evaluate the efficacy and safety of  ONO ‐2952 in females with irritable bowel syndrome with diarrhoea in an exploratory proof‐of‐concept study.    Methods  A randomised, double‐blind, placebo‐controlled study was conducted at 49  US  centres. Two hundred subjects with irritable bowel syndrome with diarrhoea (Rome  III  criteria) were randomised to  ONO ‐2952 20 mg, or 60 mg, or placebo. Subjects recorded irritable bowel syndrome symptoms daily during a 2‐week baseline period, the 4‐week treatment period and for 4 weeks post‐treatment. The co‐primary endpoints were change from baseline to week 4 in abdominal pain, stool consistency and stool frequency.    Results  Improvements in irritable bowel syndrome symptoms were seen with  ONO ‐2952 over placebo in per‐protocol analyses for all three co‐primary endpoints, but these did not reach statistical significance at the 5% level. The largest improvement was seen with  ONO ‐2952 60 mg.  ONO ‐2952 was well tolerated with a safety profile similar to that of placebo. Most adverse events were mild or moderate in severity and not treatment related.    Conclusion   ONO ‐2952 showed evidence of clinical efficacy in reducing irritable bowel syndrome‐related symptoms in female subjects with irritable bowel syndrome with diarrhoea, and further evaluation is, therefore, warranted to assess its potential as a treatment for irritable bowel syndrome with diarrhoea ( NCT 01844180).

Randomised clinical trial: exploratory phase 2 study of ONO ‐2952 in diarrhoea‐predominant irritable bowel syndrome