IBD110 is the first noninvasive gut microbiome biomarker surrogate marker of mucosal healing.
It has initially been identified in a 100 patient longitudinal cohort of Crohn’s disease (CD) patients and further validated in an independent international cohort of 300 CD patients.
The main outcome of this collaboration has been to identify a robust metagenomic marker allowing noninvasive management of patients during the course of Crohn’s disease.
For inflammatory bowel diseases like CD or UC, medical decisions are today mostly influenced by composite disease activity scores based on subjective symptom assessment which are enabling assessment of IBD and stratification of disease activity.
It is however increasingly appreciated that patient symptoms and objective parameters of inflammation can be disconnected.
Mucosal healing (MH) has emerged as an important goal in CD management. Several endoscopic scoring systems have been developed to facilitate assessment of the severity of mucosal damage at predefined sites. These instruments assess both disease extent and severity, and are now routinely used in clinical trials.
However, this procedure is invasive, costly, time-consuming, disliked by patients and drug efficacy assessment / dose adjustment are very difficult using this method. There is thus still an unmet need for a non-invasive mucosal healing / ulceration marker surrogate of endoscopy.
Some fecal markers like fecal calprotectin (FCP) are candidate but lack adequate performance and IP protection.
Gut microbiome composition appears well placed to become a source of MH surrogate marker and ultimately a relapse predictor.
We have been using whole bacterial genome shotgun sequencing of our clinical trial patient’s gut microbiomes. This technology is much more accurate than existing like 16S, and we have also demonstrated that bacterial signatures identified by shotgun can be translated into affordable qPCR kits while keeping its statistical power.