4D Pharma, a pharmaceutical company developing Live Biotherapeutic products (LBPs), has announced new faecal microbiome analyses from the completed Phase II trial of Blautix(R) (MRx1234) as a treatment for irritable bowel syndrome with constipation (IBS-C) or with diarrhoea (IBS-D). The new data was presented in an ePoster at Gastro 2021, held from December 9-11, 2021.
The study
The Phase II study was a multicentre, randomised, double-blind trial that enrolled 353 patients with IBS-C or IBS-D. Patients were treated for eight weeks with either Blautix or placebo. Microbiome composition and microbial co-occurrence network analyses were performed on 949 faecal samples from 260 subjects from the four study treatment groups (IBS-C Blautix-treated, IBS-C placebo-treated, IBS-D Blautix-treated, IBS-D placebo-treated) at baseline (week 0), mid-treatment (week 4), end of treatment (week 8), and wash-out (week 12).
The results
Treatment with Blautix led to structural changes in the gut microbiota of patients with both IBS-C or IBS-D. These changes did not occur in placebo treatment groups. Blautix treatment led to greater increases in interconnectivity between taxa than in the placebo-treated group, also in both IBS-C and IBS-D cohorts. Blautix (Blautia hydrogenotrophica) was associated with a subnetwork of multiple taxa showing high connectivity and ultimately impacting the overall microbiome structure, also in both IBS-C and IBS-D patients.
Official comments
Professor Eamonn Quigley, Head of Gastroenterology and Hepatology at Houston Methodist Hospital and the Study’s Chief Investigator, said: “The additional microbiome analyses from the Phase II study represent an interesting and important finding, further establishing the mechanisms through which Blautix exerts its beneficial effects in both IBS-C and IBS-D. The results show that administration of a single strain Live Biotherapeutic can have significant positive effects on the composition and structure of the microbiome in these patients. As a result, Blautix is an exciting novel treatment option for IBS patients. Its activity across multiple subtypes, further demonstrated with today’s data, is particularly remarkable.”
Dr. Alex Stevenson, Chief Scientific Officer, 4D Pharma, said: “These microbiome analyses are an important addition to our already significant clinical data package for Blautix. These findings from the Phase II trial, coupled with the positive outcomes of the previous post-hoc analysis, demonstrate that Blautix could provide a significant solution to address the high unmet needs of millions of patients globally with IBS. Our complimentary MicroRx and MicroDx platforms enable this level of detail regarding the mechanism of action of Blautix, along with those of 4D pharma’s pipeline of other Live Biotherapeutics across multiple indications. We continue to await feedback from the FDA which will inform our strategy for progressing Blautix as a novel treatment option for IBS patients in need.”
Looking forward
The US Food and Drug Administration (FDA) has updated 4D Pharma regarding ongoing substantial delays to its review processes as a result of the Covid-19 pandemic. As a result, 4D pharma continues to await feedback from the FDA regarding the results of its Phase II study of Blautix for the treatment of IBS and the company’s questions ahead of progression into any pivotal programme.
