4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announced that the Company has received clearance from the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Products Regulatory Authority (HPRA) to commence the Phase II study of Blautix, the Company's live biotherapeutic for the treatment of Irritable Bowel Syndrome (IBS), at sites in the UK and Ireland.
This follows an announcement made by the Company in May that the US Food and Drug Administration (FDA) had cleared the Company's Investigational New Drug application to commence the Phase II study at sites in the US. Enrolment in the study is expected to commence in the second half of 2018.
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 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 welcome this development which illustrates the international breadth of the study, set to take place at more than 10 sites across the US, UK and Ireland. This will be the largest live biotherapeutic clinical trial conducted to date and reflects our commitment to generate robust clinical data in large, well-controlled studies, which are aligned with the expectations of the regulatory authorities. We look forward to commencing enrolment of this study shortly."