11/19/2023 0 Comments 4d pharma ibsAlex Stevenson, Chief Scientific Officer, 4D pharma. 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,' said Dr. 'These microbiome analyses are an important addition to our already significant clinical data package for Blautix. Its activity across multiple subtypes, further demonstrated with today's data, is particularly remarkable.' 'As a result, Blautix is an exciting novel treatment option for IBS patients. Eamonn Quigley, Head of Gastroenterology and Hepatology at Houston Methodist Hospital and the Study's Chief Investigator. 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,' said Prof. The Gastro 2021 presentation is available via the Posters & Presentations area of the 4D pharma website at '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. 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.ĤD pharma previously announced positive initial topline 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. 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. These changes did not occur in placebo treatment groups. Treatment with Blautix led to structural changes in the gut microbiota of patients with both IBS-C or IBS-D. Microbiome composition and microbial co-occurrence network analyses were performed on 949 fecal 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). Patients were treated for eight weeks with either Blautix or placebo. The Phase II study was a multicenter, randomized, double-blind trial that enrolled 353 patients with IBS-C or IBS-D. The new data will be presented in an ePoster at Gastro 2021, held from December 9-11, 2021. Leeds - 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces new fecal microbiome analyses from the completed Phase II trial of Blautix (MRx1234) as a treatment for irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D).
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