More positive data reported from 4D Pharma trial of 'Blautix'

Biotherapeutic pharmaceutical company 4D Pharma announced additional positive data from its completed phase 2 trial of ‘LBP Blautix’ on Monday, in subjects with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D).

The AIM-traded firm said that in the post-hoc subgroup analysis in evaluable patients Blautix demonstrated statistically significant improvements in bowel habit in IBS-D, and a “strong effect” nearing significance in IBS-C, in patients across all geographic regions.

It also demonstrated consistent improvements in bowel habit in patients receiving Blautix between geographic regions.

An enhanced effect size in US patients due to a lower placebo response was reported, achieving a statistically significant improvement in bowel habit in both IBS-C and IBS-D.

Patients receiving Blautix reported progressive decreases in abdominal pain intensity over the treatment period.

After eight weeks of treatment, evaluable IBS-C and IBS-D patients receiving Blautix reported an average decrease from baseline in weekly abdominal pain scores of 29.7% and 34.4%, respectively.

Analysis of the overall response rate by geographic region demonstrated comparable response rates in patients receiving Blautix regardless of region.

The analysis did, however, identify a markedly greater placebo response in patients enrolled in the UK and Ireland, compared to those enrolled in the US.

In evaluable US patients, Blautix demonstrated a more-than-twofold greater overall response rate than placebo in IBS-D, and a clinically meaningful 73% improvement in overall response rate over placebo in IBS-C.

Placebo response rates were “notably higher” in UK and Ireland patients with IBS-C and IBS-D, however.

A “particularly strong”, statistically-significant overall response rate was observed in female IBS-D subjects across all regions, which was “enhanced and highly significant” in US female IBS-D subjects.

Subjects in all regions met the same enrolment criteria, and there were no notable differences in baseline characteristics between regions.

The company said it had discussed the high placebo response in UK and Ireland patients with international key opinion leaders and IBS patient advocate groups, and had identified a number of potential factors relating to placebo response, unrelated to study drug effectiveness, in different populations.

“Following the announcement of the topline results in October, 4D pharma has been able to review the data in more detail,” said chief scientific officer Dr Alex Stevenson.

“We have also discussed the results with internationally renowned key opinion leaders and patient groups.

“We are encouraged by the positive outcomes of this additional analysis, and we strongly believe that this signal finding study supports the continued development of Blautix as a novel treatment for IBS.”

Dr Stevenson said the phase 2 results, in conjunction with regulatory guidance and key opinion leader discussions, provided a “clear and viable” path forward for 4D Pharma to continue to develop Blautix to address a significant unmet need.

“Topline results were significantly impacted by an unusually high placebo response in certain geographical patient groups.

“Despite this, the activity of Blautix relative to placebo in this Phase II study is competitive with approved IBS therapeutics.

“With the vital learnings we have gained, we are now even more enthusiastic about the chances of success in subsequent, larger, well-powered studies.”

At 1056 BST, shares in 4D Pharma were up 3.6% at 100.5p.