January27, 2023 -
"Patient recruitment for the global phase III study CONCLUDE is under way. However, as previously communicated, lingering post-pandemic effects,
The CONCLUDE study is a phase III study evaluating the first-in-class TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. The study will include approximately 440 patients and is conducted at several hundred clinics in over 30 countries in
InDex ended 2022 with a strong cash position of
For more information:
Phone: +46 8 122 038 50
E-mail: jenny.sundqvist@indexpharma.com
Johan Giléus, deputy CEO and CFO
Phone: +46 8 122 038 50
E-mail: johan.gileus@indexpharma.com
About the CONCLUDE study
CONCLUDE is a global randomised, double-blind, placebo-controlled, clinical phase III study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis with an inadequate response or failure to tolerate conventional therapy, biological therapy or JAK inhibitors. The study has been designed in consultation with both the US and European regulatory authorities, the FDA and EMA respectively. The induction study will include approximately 440 patients, and the primary endpoint will be clinical remission at week 6, which is the same primary endpoint as used in the successful phase IIb study CONDUCT. Apart from the dosing 250 mg given at baseline and week 3, which was the highest dose and the one that showed the best efficacy in the phase IIb study, the phase III study also evaluates a higher dose, 500 mg, in an adaptive study design. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo once every three weeks.
Publication
This information is information that
This is an English translation of the Swedish press release. In case of discrepancies between the English translation and the Swedish press release, the Swedish press release shall prevail.
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 lead asset is the drug candidate cobitolimod, which is being evaluated in the phase III study CONCLUDE as a novel treatment of moderate to severe 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 the treatment of various immunological diseases.
InDex is based in
https://news.cision.com/index-pharmaceuticals/r/index-pharmaceuticals-updates-the-timeline-of-the-phase-iii-study-conclude-with-cobitolimod,c3704683
https://mb.cision.com/Main/9612/3704683/1810461.pdf
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