Treatment of Ulcerative Colitis Patients by Local Application of the Toll like Receptor-9 Agonist DIMS0150

Abstract

Background and aim: The Toll like receptor 9 (TLR9) has over the years received growing interest as a potential point of therapeutic intervention in the treatment of ulcerative colitis. The aim of this study was to evaluate a TLR9 agonist DIMS0150 as a new treatment option for patients with ulcerative colitis. Methods: A randomized, double-blind, placebo controlled, multicenter trial was conducted in ulcerative colitis patients with moderate to severe disease activity despite concomitant steroid medication. 34 patients were randomized to receive a single rectal administration of 30 mg of DIMS0150 or placebo. Results: Clinical response at week 4 was 33% and 41% in the placebo and DIMS0150 treated group, respectively. The proportion of patients in clinical remission at week 4 was 13%, observed only in the DIMS0150 group. Likewise, histological response or remission at week 4 was 27% (p-value 0.06) in the DIMS0150 group only. Rates of sustained clinical response were 27% (p-value 0.06) and 31%, in the DIMS0150 treated group across week 4 and 3 months respectively. Sub score analysis of the disease activity indices indicated a highly statistical difference at week 4 from baseline only in the DIMS0150 treated group for all 4 DAI sub scores. Conclusion: Although statistical significant results for the primary endpoints could not be obtained in this small study, DIMS0150 treatment showed positive signals suggesting that TLR-9 activation could be an interesting upcoming therapeutic option.