InDex Pharmaceuticals to present results from the COLLECT trial at the 10th Congress of the European Crohn's and Colitis Organisation
February 3, 2015 - InDex Pharmaceuticals today announced that results from COLLECT, a clinical study of the toll-like receptor 9 (TLR9) agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis, will be subject to an oral presentation at the 10th Congress of the European Crohn's and Colitis Organisation (ECCO). The congress is to be held in Barcelona, Spain on February 18-21, 2015.
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis and inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. The study was conducted at 40 sites in seven European countries.
Despite not meeting the primary endpoint of inducing clinical remission measured at week 12, defined by a clinical activity index (CAI) score of ≤4, Kappaproct showed statistically significant improvement on important secondary endpoints at week 4 and 8, including symptomatic remission (blood in stool, number of stools) and registration remission (clinical remission with concurrent endoscopic remission) as well as rate of colectomy at week 22. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident. The data strongly support continued development of Kappaproct as a promising and well-tolerated novel therapeutic option for refractory ulcerative colitis patients. The next phase III study is planned to start this year.
The presentation (Oral presentation #15) titled "Multicentre clinical trial with topical administration of the Toll-Like receptor 9 agonist DIMS0150 shows evidence for efficacy in moderate to severe Ulcerative Colitis" will be held by Professor Raja Atreya from the University of Erlangen-Nürnberg on Friday, February 20th, 2015, at 14.20pm CET.
For further information, please contact:
Prof. Dr. Thomas Knittel, CMO, InDex Pharmaceuticals
Tel: +49 173 356 4980
Media Inquiries InDex:
Dr. Ludger Wess or Ines-Regina Buth
Tel.: +49 (0)40 88 16 59 64 / +49 (0)30 2363 2768
TO THE EDITORS
In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis with inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. Concominant use of TNF-α inhibitors was excluded. The study was conducted at 40 sites in seven European countries. Kappaproct was administrated as two single rectal doses, given at week 0 and week 4. The primary endpoint was clinical remission (Rachmilewitz/CAI score of ≤4) measured at week 12. There was an unexpectedly high remission rate in the control group and there was no statistically significant difference observed on this measure. Statistically significant effects were demonstrated on the secondary endpoints symptomatic remission (blood in stool = none, number of stools weekly <35) at week 4 and 8, on registration remission (Rachmilewitz/CAI score of ≤4, plus an endoscopic Mayo score of 0 or 1) at week 4 as well as on the rate of colectomy at week 22. The patients were followed for one year from the first dose to evaluate long-term efficacy and safety. More information about the study can be found on clinicaltrials.gov (NCT01493960).
About InDex Pharmaceuticals
InDex Pharmaceuticals develops Kappaproct® - a new type of drug that can help patients with moderate to severe ulcerative colitis back to a normal life. InDex has out-licensed the European right for Kappaproct to Almirall SA.
The company is based in Stockholm. Among the main shareholders are SEB Venture Capital, Industrifonden and NeoMed Management. For more information, please visit www.indexpharma.com
Kappaproct, a DNA-based immunomodulatory sequence (DIMS) targeting the toll like receptor 9 (TLR9), is a new type of drug that provides a local anti-inflammatory effect in the intestine, which leads to mucosal healing and alleviation of clinical symptoms. Kappaproct also has a favorable safety profile compared to other drugs in the field.
Contact // Kontakt akampion Newswire:
Dr. Ludger Wess
Managing Partner, akampion
T: +49 (0)40 88 16 59 64
F: +49 (0)40 88 16 59 65
Managing Partner, akampion
T: +49 (0)30 23632768
F: +49 (0)30 23632769