InDex Pharmaceuticals Holding has entered an agreement for services with the global contract research organization (CRO) PAREXEL for the implementation of the CONDUCT study.
The CONDUCT is a phase IIb dose optimisation study with the drug candidate cobitolimod for the treatment of moderate to severe active ulcerative colitis.
According to the agreement, the first patient in the CONDUCT study will be enrolled during the second quarter of 2017 and the objective is to have top line results from the study in the fourth quarter of 2018. The study will be conducted at approximately 90 sites in 12 different countries: Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Sweden and Ukraine. Many sites would like to participate and of more than 100 visted interested sites, 60 have already qualified to take part in the study. The process of getting the study approved by regulators and ethics committees in each country is underway. The study will not include any US sites due to the high cost per patient.
“We are very pleased to have PAREXEL as our partner for this important trial with cobitolimod, our lead drug candidate”, says Peter Zerhouni, CEO of InDex Pharmaceuticals. “It is a leading global CRO with considerable experience from managing multinational clinical studies in inflammatory bowel disease. We are now working together to advance the CONDUCT study as efficiently and quickly as possible.”
The CONDUCT study will include 215 patients with left-sided moderate to severe active ulcerative colitis, divided into four treatment arms receiving 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.
Based on the results of earlier clinical trials with cobitolimod this study will evaluate other doses and dose frequencies than previously investigated in order to optimise the treatment. The goal is, while maintaining the compound’s excellent safety profile, to show a substantially higher efficacy than in prior studies and also in comparison with what has been reported for drugs on the market as well as other compounds in late stage clinical development.