LONDON (Alliance News) - 4D Pharma PLC on Tuesday said results from its phase 1 clinical trial for Blautix may indicate its treatment has a "relevant therapeutic effect", and the group said it will investigate further in a phase 2 clinical trial.
Blautix is 4D's treatment for irritable bowel syndrome and, earlier in the clinical trial, it was shown to be safe and well-tolerated. Trends from analysis had indicated irritable bowel syndrome subjects showed greater levels of symptom relief than those receiving a placebo.
4D Pharma on Tuesday said further patient sample analysis focused on both the stability and diversity of the microbiome, both of which are typically reduced in IBS patients compared with healthy volunteers.
In the study, the group said IBS patients receiving Blautix showed an "an increase in microbiome diversity and microbiome stability that was comparable to healthy controls". Meanwhile, IBS patients receiving a placebo showed a reduction in microbiome diversity and exhibited microbiome instability over the period of the trial.
4D said it will investigate this further in its Phase II clinical trial scheduled for 2017.
"Reduction in the stability and diversity of the microbiome is a recognised aspect of IBS pathophysiology. These results demonstrate that Blautix, our single strain live biotherapeutic for the treatment of IBS, is able to increase the stability and diversity of the microbiome in IBS patients," said Chief Scientific Officer Alex Stevenson.
"In addition to the previously reported results, this finding is very encouraging for the future clinical development of Blautix and our other single strain live biotherapeutic products," Stevenson added.
By Hannah Boland; hannahboland@alliancenews.com; @Hannaheboland
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