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).