Kappaproct Drastically Reduces the Need for Colectomy in Patients with Severe Ulcerative Colitis

– InDex Pharmaceuticals reports positive clinical data in peer-reviewed journal Inflammatory Bowel Diseases –

Stockholm, June 19, 2012 – InDex Pharmaceuticals today 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.

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).

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.

“We are very happy about the results from the compassionate use program,” said Jesper Wiklund,   CEO of InDex Pharmaceuticals. “They underline the ability of Kappaproct to induce clinical remission in the most severe steroid-refractory UC patients, who have been selected for the surgical removal of parts of their colon. This provides the prospect to reduce the need for colectomy on a long-term basis. For severe ulcerative colitis patients, there is a high unmet medical need, and successful treatment with Kappaproct would dramatically improve the lives and prospects of these critically ill patients.”

About Kappaproct
Kappaproct is a single-strand, DNA-based synthetic oligonucleotide. It functions as an immunomodulatory agent by targeting TLR9. In a Phase II trial, Kappaproct has shown positive  effects in the treatment of steroid resistant ulcerative colitis patients. Kappaproct has received orphan drug designation in Europe. A European multicenter Phase III study, COLLECT, is currently being conducted to evaluate the efficacy and safety of Kappaproct for the treatment of chronic active ulcerative colitis patients not responding to available therapy. More information about the study can be found on clintrials.gov with the ClinicalTrials.gov Identifier NCT01493960.