Irritable bowel syndrome (Blautix)
In 2016 we completed a Phase Ib study of Blautix, our live biotherapeutic candidate for irritable bowel syndrome. The trial was a placebo-controlled study and enrolled 24 IBS patients and 24 healthy volunteers.
The study met its primary objective of demonstrating that Blautix was safe and well tolerated. We were also able to obtain preliminary insights into the clinical effectiveness and mechanism of the drug. Encouragingly, we saw a greater proportion of Blautix-treated patients showing improvements in their IBS symptoms compared with patients receiving placebo. We also noted a greater proportion of the Blautix treatment group exhibiting a reduction in hydrogen breath levels – a biomarker of the drug’s activity. Analysis of patient samples using our proprietary microbiome profiling platform, MicroDx, showed that the administration of Blautix resulted in an increase in microbiome diversity.
Although based on a relatively small sample size, these observations are in line with preclinical data and strengthen the evidence of the proposed mechanism of action for Blautix in the treatment of IBS. Moreover, these encouraging early clinical results provide a solid basis for progressing Blautix into larger studies and further evaluation as a potential treatment for IBS.
We expect to open a phase II study of Blautix in IBS-C and IBS-D patients later in 2018 in Europe and the USA. Patient samples from those studies will be analysed using MicroDx.
Paediatric Crohn’s disease (Thetanix)
We have recently completed dosing for a first-in-man study of Thetanix in paediatric patients with Crohn's disease. The trial has primarily investigated the safety and tolerability of Thetanix and we expect to announce results later this year.
We expect to open a phase II study of Thetanix in adults with Crohn's disease later in 2018.