4D pharma plc 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). The new data will be presented in an ePoster at Gastro 2021, held from December 9-11, 2021. The Phase II study was a multicenter, randomized, 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 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). 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. 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. The Blautix® Phase II clinical trial (ClinicalTrials.gov identifier: NCT03721107) is a multicenter, randomized, placebo-controlled study that enrolled a total of 353 patients with IBS-C or IBS-D with eligible baseline data (158 and 195 patients, respectively). Patients in each cohort were randomized 1:1 to receive either Blautix or placebo; in total, 76 IBS-C patients and 94 IBS-D patients received Blautix treatment. Blautix or placebo was administered orally as two capsules, twice daily for eight weeks.