InDex Pharmaceuticals presents results from the COLLECT study at the United European Gastroenterology Week 2016

In the COLLECT study, 131 patients with moderate to severe active ulcerative colitis, not responding to conventional therapy, received either cobitolimod or placebo in addition to standard of care treatment. The study was conducted at 38 centers in seven European countries. Patients were randomized to receive two doses of 30 mg cobitolimod or placebo at week 0 and 4. Main results from the study have recently been published in the Journal of Crohns and Colitis (Atreya et al. J Crohns Colitis 2016 May 20 Epub ahead of print). The results support the potential of cobitolimod as a novel treatment for moderate to severe active ulcerative colitis. Statistically significant differences between cobitolimod and placebo were observed already after four weeks in several important efficacy endpoints currently recommended by regulatory authorities and considered as the most clinically relevant.

Additional subgroup analyses of data from the COLLECT study, which will be presented during UEGW, suggest that cobitolimod can induce clinical remission both in patients with moderate and in patients with severe disease activity, as well as in patients who have previously tried anti-TNF-alpha therapy and in patients who have not tried anti-TNF-alpha therapy.

UEGW is the largest scientific meeting for gastroenterologists in Europe.

The presentation (Oral presentation #107) with the title Clinical Disease Activity Influences the Therapeutic Efficacy of the Toll-like Receptor 9 Agonist Cobitolimod in Patients with Moderate to Severe Active Ulcerative Colitis will be given by Professor Raja Atreya from the University of Erlangen-Nürnberg on Monday, October 17, 2016 at 16:45 CET during the session Future Drugs in IBD.

The poster with the title Clinical Efficacy of the Toll-like Receptor 9 Agonist Cobitolimod in Anti-TNF-antibody Treated and Naïve Patients with Moderate to Severe Active Ulcerative Colitis will also be presented by Professor Raja Atreya during the Poster Champ Session on Wednesday, October 19, 2016 at 12:30 CET. The poster has received the recognition Poster of Excellence by UEGW.

For more information:
Peter Zerhouni, CEO
Phone: +46 8 508 847 35
E-mail: peter.zerhouni@indexpharma.com

InDex Pharmaceuticals in brief
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The Company’s foremost asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe active ulcerative colitis – a debilitating, chronic inflammation of the large intestine.

Cobitolimod is a new type of drug that can help patients with moderate to severe ulcerative colitis back to a normal life. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in treatment of various immunological diseases.

InDex is based in Stockholm with address Tomtebodavägen 23a, 171 77 Stockholm, Sweden. The Company’s operations are mainly conducted through its subsidiary InDex Pharmaceuticals AB. Trading in InDex shares begins on Nasdaq First North Stockholm on the 11th of October, 2016. Redeye AB will be the company’s Certified Adviser. For more information, please visit www.indexpharma.com.

Cobitolimod in brief
Cobitolimod has a new type of mechanism of action. It is a so-called Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.

Cobitolimod has achieved clinical proof-of-concept in moderate to severe active ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials indicate that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively.

In January 2016, WHO recommended the INN name cobitolimod. The substance is also known as Kappaproct® and DIMS0150.