4D pharma plc, a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, 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 diarrhea (IBS-D). The new data was presented in an ePoster at Gastro 2021, held from December 9-11, 2021.
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).
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.
4D pharma previously announced positive initial top line results from the Phase II trial in October 2020 and presented further positive results of additional post-hoc analyses at Digestive Disease Week (DDW) in May 2021. The Gastro 2021 presentation is available via the Posters & Presentations area of the 4D pharma website.
Prof. Eamonn Quigley, Head of Gastroenterology and Hepatology at Houston Methodist Hospital and the Study’s Chief Investigator, commented “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.”
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 program.