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4D pharma gets European approval for next Blautix study
Pharmaceutical company 4D pharma 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', it announced on Wednesday.
The AIM-traded company said Blautix is a live biotherapeutic for the treatment of irritable bowel syndrome (IBS), with the trial to take place at sites in the UK and Ireland.
It followed an announcement made by the firm in May that the US Food and Drug Administration (FDA) had cleared its Investigational New Drug application to commence the Phase II study at sites in the US.
Enrolment in the study was expected to start in the second half of 2018.
4D said the double-blind, placebo-controlled multicentre Phase II study would evaluate the efficacy and safety of Blautix in patients with IBS with constipation (IBS-C) and IBS with diarrhoea (IBS-D).
The company said it had consulted with the FDA on the design of the study, with up to 500 patients to receive either Blautix or placebo daily for eight weeks.
4D explained that the primary endpoint would 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 four out of eight weeks.
A range of secondary efficacy endpoints would also be assessed, as well as the effects of Blautix on the gut microbiome.
"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," said 4D pharma's chief scientific officer Dr Alex Stevenson.
"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."