March 22, 2017 – InDex Pharmaceuticals Holding AB (publ) today announced that the company hosted a well attended investigators’ meeting for the CONDUCT study on March 20-21, 2017 in Stockholm. CONDUCT is a phase IIb dose optimisation study with the drug candidate cobitolimod for the treatment of moderate to severe active ulcerative colitis.
The meeting gathered physicians, study nurses and study coordinators from 65 clinics in 11 countries together with personnel from InDex and the contract research organization (CRO) PAREXEL. A total of almost 170 attendees participated in the meeting which was held in the Nobel prize lecture hall Aula Medica at Karolinska Institutet in Stockholm, Sweden. The aim of the meeting was for the InDex and PAREXEL study team to meet with the site staff and go through the CONDUCT study, to ensure that it is conducted in compliance with the clinical study protocol, guidelines and applicable regulations.
“Investigators’ meetings are critical to the success of clinical trials and we are very pleased with the high attendance and great interest in cobitolimod and the CONDUCT study at our meeting”, said Peter Zerhouni, CEO of InDex Pharmaceuticals. “We really appreciate the attendees taking time from their busy schedules for these two intensive and fruitful days and we would like to thank all participants for making this event a success.”
Professor Raja Atreya at the University of Erlangen-Nürnberg and principle investigator of the CONDUCT study added, “It feels great to be part of this important study where we are around 90 clinics in 12 European countries collaborating. I look forward to working with my colleagues from all these places to quickly enrol the patients and to make it the best possible study. Cobitolimod is a very promising novel therapeutic option for this debilitating condition and I hope that we will have a real breakthrough with this study for the benefit of patients.”
The CONDUCT study will include 215 patients with left-sided moderate to severe active ulcerative colitis, divided into four treatment arms receiving different dosages of cobitolimod and one arm receiving placebo. It is a randomised, double blind, placebo controlled study for evaluating cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo. In addition to cobitolimod or placebo, all patients will receive standard of care treatment. The objective is to have the first patient enrolled during the second quarter of 2017 and to have top line results in the fourth quarter of 2018.
Cobitolimod in brief
Cobitolimod is a new type of drug that can help patients with moderate to severe ulcerative active colitis back to a normal life. 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. Cobitolimod is also known as Kappaproct® and DIMS0150.
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. 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, Sweden. The company’s shares are traded on Nasdaq First North Stockholm. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com