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4D Pharma PLC said on Wednesday that its Blautix phase 2 clinical trial results showed the treatment had a positive effect on sufferers of irritable bowel syndrome
Findings from the probe have been published in the journal Alimentary Pharmacology & Therapeutics.
The Leeds-based pharmaceutical firm said the results specifically indicated Blautix aided key regulator-defined symptoms of IBS and altered bowel habits for both IBS with predominant constipation or predominant diarrhoea patients.
It also found the safety profile of Blautix to be comparable to placebo.
"This study represents one of the first, if not the first, clinical trial of a live biotherapeutic in irritable bowel syndrome," said Eamonn Quigley, the study's chief investigator and head of gastroenterology and hepatology at Houston Methodist Hospital.
"While the primary outcome was not achieved, results in secondary outcomes and post-hoc analyses revealed signals supportive of efficacy and provide some confidence that this may represent a new approach to the management of this challenging disorder."
Administrators for 4D Pharma PLC were appointed on June 24, but had no oversight or involvement in the preparation of the journal publication.
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