Date: 2012-06-19
Type of information:
phase:
Announcement: publication of results. The article “Topical Treatment with the Toll-like Receptor Agonist DIMS0150 Has Potential for Lasting Relief of Symptoms in Patients with Chronic Active Ulcerative Colitis by Restoring Glucocorticoid Sensitivity”, was published in the journal Inflammatory Bowel Diseases (DOI 10.1002/ibd.23019).
Company: InDex Pharmaceuticals (Sweden)
Product: Kappaproct®
Action mechanism: Kappaproct® (DIMS0150) is a modified single strand DNA-based synthetic oligodeoxyribonucleotide of 19 bases in length. The drug functions as an immunomodulatory agent by targeting the Toll-like receptor 9 (TLR9) present in immune cells residing in high abundance on mucosal surfaces, such as colonic and nasal mucosa. The mucosa of the colon and rectum of patients with ulcerative colitis contains active immune cells, which produce damage to the tissue. The activation of these cells by Kappaproct® results in the systemic release of specific cytokines (e.g., IL-10 and type I interferons) and chemokines which are believed to be important factors for the clinical effect of Kappaproct. Ex vivo experiments with Kappaproct have demonstrated that the drug has the ability to enhance the steroid sensitivity of peripheral blood mononuclear cells obtained from steroid refractory UC patients. Thus, the desired effect is to restore steroid sensitivity in steroid refractory patients such that they may benefit from the anti-inflammatory actions of the steroid and ultimately become steroid free.
Disease: refractory ulcerative colitis
Therapeutic area: Inflammatory diseases - Autoimmune diseases
Country:
Trial details:
Latest
news: InDex Pharmaceuticals has announced the publication of positive data from the Company\'s compassionate use program with its lead compound Kappaproct®. In the program, eight treatment-refractory ulcerative colitis (UC) patients that had been elected for colectomy received Kappaproct®, a DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9).
The findings showed that Kappaproct® induced a pronounced and rapid reduction in the colitis activity index for all treated patients within 1 week following a single intracolonic administration. Further improvements were evident at week 4, resulting in a clinical response rate after a single-dose treatment with Kappaproct of 71%, with 43% in clinical remission.
By week 12, the clinical response and remission rates had reached 82% and 71%, respectively. A follow-up period of over 2 years post treatment indicated that all but one of the treated patients had avoided the need for colectomy, with the longest patient being in symptom-free remission for over 27 months.
Kappaproct® is currently in a European multicenter phase III trial called COLLECT (NCT01493960) for the treatment of chronic active UC patients not responding to available therapy. Results are expected for Q1 2014.
