Gut Inc.

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.


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).