Overview
Orally-active RNA oligonucleotides for inflammatory bowel disease (IBD)
GUT Inc. focused on the development of therapeutic RNA oligonucleotides in IBD. We target a matrix remodeling gene which is highly expressed in colonic mucosa in IBD patients with infliximab non-responder. GUT-1 is locally injectable RNA oligonucleotide, and the positive clinical outcomes in Phase IIa and investigator-initiated trials were demonstrated in ulcerative colitis (UC) patients who showed loss of response to TNF antagonists. We now identified GUT-2, a novel orally feasible RNA oligonucleotide, having the equivalent antisense sequence of GUT-1.
News
2025.11.1
GUT Inc. is pleased to announce that the Company has entered into a collaborative research agreement with Dokkyo Medical University.
Under the agreement, GUT Inc. and Dokkyo Medical University will jointly conduct pharmacokinetic and efficacy studies, including animal studies, using GUT Inc.’s CHST15-targeting oligonucleotide therapeutics.
The collaborative research will be led by Professor Nobuko Tokuda and Associate Professor Hisashi Ueta from the Department of Anatomy at Dokkyo Medical University.
The research aims to further evaluate the pharmacological properties and therapeutic potential of GUT Inc.’s novel CHST15-targeted nucleic acid medicines.
2025.5.28
GUT Inc. is pleased to announce that Professor Markus F. Neurath and Professor Raja Atreya have joined the Company’s Advisory Board.
Professor Markus F. Neurath is a globally recognized expert in gastroenterology and inflammatory bowel disease (IBD) research. He serves as Chair of Internal Medicine at Friedrich-Alexander University Erlangen-Nürnberg and has made major contributions to the understanding and treatment of intestinal inflammation.
Professor Raja Atreya is a leading specialist in translational immunology and IBD therapeutics at the University Hospital Erlangen. His research focuses on precision medicine and novel treatment approaches for inflammatory bowel diseases.
The appointments further strengthen GUT Inc.’s scientific leadership as the Company advances the development of its CHST15-targeting therapeutic platform.
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.