DDW presentation22 May 2021 10:28
So I went on the DDW website to view when the presentation will be. It's at 12.15 to 1pm EST today. So about 5pm UK time if I am that right. Also, I found the paper attached to the presentation. So below:
A PHASE II STUDY OF LIVE BIOTHERAPEUTIC BLAUTIX IN IRRITABLE BOWEL SYNDROME (IBS) PATIENTS WITH SUBTYPES IBS-D AND IBS-D
Presentation Number: Sa607
Background
Current treatments target subset-specific symptoms of IBS with constipation (IBS-C) or diarrhoea (IBS-D). Blautix (Blautia hydrogenotrophica) is a human gut microbiome-derived, oral Live Biotherapeutic, with potential as a disease-modifying therapy for IBS, addressing functional microbiota abnormalities.
To evaluate the clinical efficacy of Blautix and to define key parameters for a pivotal program we conducted a Phase II randomised, double blind, placebo-controlled, parallel group, multi-center, study in patients with IBS-C or IBS-D.
Methods
353 pts with IBS-C or IBS-D with eligible baseline data (158 and 195 pts respectively) were randomised 1:1 to receive Blautix or placebo BID for 8 weeks, with 4 week follow-up period.
The primary endpoint was overall responder rate (ORR) in IBS-C or IBS-D cohorts in the Full Analysis Set (N=353). Overall responders must have improvement in weekly symptoms (abdominal pain intensity and stool frequency (IBS-C) or consistency (IBS-D)) for =50% of treatment period. ORR was also assessed in the combined IBS-C/D group and the Efficacy Evaluable Analysis Set (N=319) - all pts who completed the 8-week treatment and assessment period without major protocol violations, identified in a blinded data review.
Secondary and exploratory endpoints include bowel habit (stool frequency or consistency) and abdominal pain independently, fecal microbiota analysis, and safety. Pearson’s test with Yates’ correction was used to calculate P values, no corrections were made for multiple testing. Study was designed to demonstrate statistical difference at a one-sided P value <0.1 at a placebo response rate of 40%.
Results
The number of IBS-C and IBS-D pts receiving Blautix or placebo who were overall responders are shown in Table 1.
The number of IBS-C and IBS-D pts receiving Blautix or placebo with overall improvement in bowel habit are shown in Table 2.
In the EEAS overall improvement in abdominal pain occurred in 33.8% IBS-C pts receiving Blautix vs 24.4% placebo (P=0.2), and 49.4% vs 42.7%, respectively, in IBS-D pts (P=0.236). Analsysis of the combined IBS-C/D group showed overall improvement in abdominal pain in 42.1% for Blautix vs 34.1% for placebo (P=0.069).
Further work is ongoing in relation to exploratory and subgroup analyses.
Blautix showed a highly favourable safety profile with no treatment related SAEs. Across Blautix and placebo treatment groups respectively, 32.8% and 33.0% pts experienced AE(s).
Sign In
Follow the stocks
