22 March 2017
InDex Pharmaceuticals concludes well attended Investigators’ Meeting for the phase IIb study CONDUCT
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.