A clinical study to optimize treatment with cobitolimod
Based on the encouraging results from earlier studies, InDex performed a phase IIb study to evaluate other doses and dose frequencies than investigated in previous clinical studies with cobitolimod. The study objective was to identify the dose regimen for further development.
The CONDUCT study met its primary endpoint with an outstanding combination of efficacy and safety and clearly demonstrated that it was the highest dose of cobitolimod, 250 mg x 2, that was the most effective. Top line results were released on 27 August 2019 and full data presented in the Lancet Gastroenterology and Hepatology on 6 October 2020.
The primary endpoint, clinical remission at week 6, was achieved in 21.4 percent of patients treated with two doses of 250 mg cobitolimod, which was statistically significantly better (p-value = 0.025) than patients treated with placebo where only 6.8 percent of the patients achieved clinical remission, i.e. a difference (delta) of 14.6 percent. No statistically significant difference was noted between the other doses of cobitolimod and placebo. The results in secondary endpoints also confirm the efficacy of the highest dose. Thus, the CONDUCT study fulfilled its objectives in both the primary and a number of clinically relevant secondary endpoints. Cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo.
The CONDUCT study in brief
The CONDUCT study was a randomized, double blind, placebo-controlled study to evaluate cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo. The study included 213 patients with left-sided moderate to severe active ulcerative colitis, divided into four treatment arms receiving cobitolimod and one arm receiving placebo. In addition to cobitolimod or placebo, all patients continued with their standard of care treatment. The patients were followed for a total of 10 weeks.
Professor Raja Atreya at the University of Erlangen-Nürnberg in Germany was the principal investigator of the CONDUCT study and Professor Walter Reinisch at the Medical University of Vienna was Medical Advisor. The study was conducted at 91 sites in 12 different European countries: the Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Sweden and the Ukraine respectively. For more details on the study, please visit www.clinicaltrials.gov/show/NCT03178669
CONDUCT is short for CObitolimod as Novel DNA-based Ulcerative Colitis Treatment.