InDex Pharmaceuticals Holding announces that the first patient has been enrolled in the clinical study CONDUCT, a phase IIb dose optimisation study with the drug candidate cobitolimod.
Cobitolimod is an immunotherapeutic, which is being developed for the treatment of moderate to severe active ulcerative colitis. The CONDUCT study will include 215 patients with left-sided moderate to severe active ulcerative colitis at 90 sites in 12 countries. It is a randomised, double blind, placebo-controlled study for evaluating cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo. The dose optimisation study investigates three different dose strengths of cobitolimod and two different dose frequencies.
“This is an important milestone for InDex and represents another step towards our mission of providing more effective and safer drugs for this unmet medical need. SEK 250 million was raised in our IPO in October 2016, primarily to finance the CONDUCT study, and we are delivering according to plan”, said Peter Zerhouni, CEO of InDex Pharmaceuticals. “The goal of CONDUCT, while maintaining cobitolimod’s excellent safety profile, is to show a substantially higher efficacy than in previous studies, and also in comparison with what has been reported both for drugs on the market and other compounds in late stage clinical development for moderate to severe active ulcerative colitis.”
The study is conducted in collaboration with the biopharmaceutical services company PAREXEL. Study drug for the complete study has been manufactured at APL in Sweden.