June 27, 2014 – InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.
Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.
“The results of COLLECT provide a good basis for the further development of Kappaproct in Ulcerative Colitis”, said Jesper Wiklund, CEO of InDex Pharmaceuticals. “The trial demonstrated proof-of-concept for this novel treatment approach. Most importantly, the endpoints reached are highly relevant from both a regulatory and clinical perspective and we have no safety signals evident. Following final analysis of the study data, we will meet with regulatory agencies in Europe and the US to discuss clinical development plans and the path to approval in those geographies.”
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.
For further information, please contact:
Jesper Wiklund, CEO, InDex Pharmaceuticals
Tel: +46 8 508 847 35/ +46 (0)733 59 05 53
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
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.