Overview
GUT Inc. targets tissue remodeling and fibrosis, key drivers of structural damage of the inflamed bowel in Inflammatory bowel disease (IBD)
GUT Inc. focuses on the clinical development of RNA oligonucleotides in IBD. We and others have shown that intestinal fibrosis, which is characterized by excessive deposition of extracellular matrix (ECM) components by activated cells of mesenchymal origin in the intestinal wall, is the basis of several gastrointestinal disorders, in particular IBD. By systematically addressing the factors that mediate fibrosis we have been able to identify mechanistically-driven novel approaches that have now been translated into positive clinical outcomes in IBD. We have completed successful Phase IIa clinical trial in Ulcerative Colitis.
News
2024.4.25
The results from Independent Investigational Trial (IIT) study of GUT-1 as an add-on therapy for moderate-to-severe ulcerative colitis were published in the Inflammation and Regeneration.
Suzuki K et al., Add-on multiple submucosal injections of the RNA oligonucleotide GUT-1 to anti-TNF antibody treatment in patients with moderate-to-severe ulcerative colitis: an open-label, proof-of concept study.
Inflammation and Regeneration, 2024, 44, Article number: 22
https://pubmed.ncbi.nlm.nih.gov/38664814/
This was a single arm IIT study in Japan.
In moderate-to-severe UC patients who lost response to TNF antagonists (n=5), add-on multiple injections of GUT-1 (250 nM) to TNF antagonist therapy as an induction therapy showed:
- 60% of clinical remission at week 6.
- 80% of endoscopic improvement at week 6.
- 80% of histological improvement at week 6.
The results would also provide new insights into treatment concept of biologics-maintenance therapy – Adding local therapy of distinct MOA like GUT-1, rather than simply switching, would be an alternative option for chronic disease like UC that repeats relapses and remissions.
2024.3.1
The results from Phase 2a clinical study of GUT-1 in active ulcerative colitis patients were published in the Journal of Crohn’s and Colitis.
Atreya R et al., Submucosal Injection of the RNA Oligonucleotide GUT-1 in Active Ulcerative Colitis Patients: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Induction Trial.
Journal of Crohn’s and Colitis, 2024, 18 (3), 406-415.
https://pubmed.ncbi.nlm.nih.gov/37777210/
This was a phase IIa RCT in Germany (PI: Prof. Markus Neurarh, Erlangen Univ.).
In moderate-to-severe UC patients (n=24) whose previous TNF antagonists were washed-out for 4 weeks, single injection of GUT-1 (250 nM) as an induction therapy showed:
- 57.1% of clinical remission (vs placebo 14.3%) by week 4.
- 71.4% of endoscopic improvement (vs placebo 28.6%) by week 4.
- 42.9% of histological improvement (vs placebo 0.0%) by week 4.
2023.7.6
GUT Inc. is pleased to announce that the abstract of IIT study results with GUT-1 has been accepted as “Moderated Poster Presentation” at the UEG Week (Copenhagen in October 14-17).