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Hindi Research Article
Treatment of Ulcerative Colitis Patients by Local Application of the Toll like Receptor-9 Agonist DIMS0150
Robert Löfberg1, Thomas Knittel2, Charlotte Admyre2, Petra von Stein2, Ragnar Befrits3, Arezou Zargari2*, Jan Kowalski4 and Oliver von Stein2
1Stockholm Gastro Center, Sophiahemmet, Stockholm, Sweden and Department of Medicine, Karolinska Institutet, Solna, Sweden
2InDex Pharmaceuticals, Tomtebodavägen 23a, SE-171 77, Stockholm, Sweden
3Dept of Gastroenterology, Karolinska Hospital, Stockholm, Sweden
4JK Biostatistics AB, Jönköping, Sweden
- *Corresponding Author:
- Arezou Zargari
InDex Pharmaceuticals AB, Tomtebodavägen 23a
SE-171 77, Stockholm, Sweden
Tel: 0046 8 50884738
Fax: 0046 8 508 847 31
E-mail: arezou.zargari@indexpharma.com
Received date: October 08, 2014; Accepted date: December 18, 2014; Published date: December 25, 2014
Citation: Löfberg R, Knittel T, Admyre C, von Stein P, Befrits R, et al. (2014) Treatment of Ulcerative Colitis Patients by Local Application of the Toll like Receptor-9 Agonist DIMS0150. J Gastrointest Dig Syst 4:243. doi:10.4172/2161-069X.1000243
Copyright: © 2014 Löfberg, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.
