Positive data 4D pharma's Blautix in irritable bowel syndrome

UK-based 4D pharma (AIM: DDDD) today announces additional positive data from its completed Phase II trial of its single strain live biotherapeutic product (LBP) Blautix in subjects with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D). The company’s shares ere up 3.6% at 100.46 pence in early trading.

The data has been presented at Digestive Disease Week (DDW), on May 22, 2021, by Professor Eamonn Quigley, head of gastroenterology and hepatology at Houston Methodist Hospital, Professor of Medicine at Weill Cornell Medical, and chief investigator of the study.

4D pharma previously announced top-line efficacy and safety results from the trial, conducted in the USA, UK and Ireland, in October 2020. Further analysis of the data has revealed strong and statistically-significant activity on the key symptom of bowel habit, a potential approvable primary endpoint per regulatory guidelines. In addition, analysis of the data by geographical region shows that earlier top-line results were impacted by an unusually high placebo response in patients in the UK and Ireland, and enhanced positive signals were seen in the larger US population.