4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, t0day announced the randomisation of the first patient in a Phase II clinical trial of Blautix in patients with Irritable Bowel Syndrome (IBS). The study will recruit up to 500 patients at sites across the US and EU and is set to be the largest clinical trial of a Live Biotherapeutic conducted to date.
The double-blind, placebo-controlled multicentre Phase II study will evaluate the efficacy and safety of Blautix in patients with IBS with constipation (IBS-C) and/or IBS with diarrhoea (IBS-D). The Company has consulted with the FDA on the design of the study. Up to 500 patients will receive either Blautix or placebo daily for 8 weeks. The primary endpoint will be the Overall Response rate, defined as the proportion of patients reporting an improvement in their weekly cohort-specific symptoms (abdominal pain and stool frequency or consistency) for at least 4 out of 8 weeks. A range of secondary efficacy endpoints will also be assessed, as well as the effects of Blautix on the gut microbiome.
Dr. Alex Stevenson, 4D’s Chief Scientific Officer, commented: “We are delighted to have enrolled the first patient in this important study, which brings us another step towards making Blautix available for patients. IBS remains an area of significant unmet need, with existing treatments limited to symptom management and many patients struggling to achieve relief. By targeting the gut microbiome, Blautix targets the underlying pathophysiology of IBS and has the potential to fundamentally change the way these patients are treated.”