February 27, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that the company will attend the annual congress of the European Crohn’s and Colitis Organisation (ECCO), March 1-4, 2023 in Copenhagen. ECCO is the largest forum for specialists in inflammatory bowel disease globally.
InDex Pharmaceuticals will also be present at booth #C3-17 in the exhibition hall at the Bella Center. InDex’s team members will be available on site to provide information about cobitolimod and the ongoing phase III program CONCLUDE, which is evaluating the Toll-like receptor 9 agonist cobitolimod, as a potential novel treatment for moderate to severe left-sided ulcerative colitis. In addition, InDex’s team member will take the opportunity to meet Investigators of Induction 1 study of the CONCLUDE program to discuss study progress with the coordinating Investigator Professor Raja Atreya.
"ECCO is the largest forum for specialists in inflammatory bowel disease in the world and a very significant industry and healthcare professional event,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals. “ECCO provides a great opportunity for the team to further interact with healthcare professionals, potential partners and relevant stakeholders to progress our lead drug candidate cobitolimod and the phase III program CONCLUDE.”
For more information:
Jenny Sundqvist, CEO
Phone: +46 8 122 038 50
E-mail: [email protected]
Johan Giléus, deputy CEO and CFO
Phone: +46 8 122 038 50
E-mail: [email protected]
About the CONCLUDE program
The phase III program CONCLUDE is evaluating 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 program consists of two sequential induction studies and a one-year maintenance study with patients who have responded to cobitolimod as induction therapy.
Induction Study 1 of the phase III program CONCLUDE is a global randomised, double-blind, placebo-controlled, clinical phase III study designed in consultation with both the US and European regulatory authorities, the FDA and EMA respectively. The 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. Upon a positive read-out of Induction Study 1, InDex plans to initiate Induction Study 2.
Publication
The information was submitted for publication through the agency of the contact person set out above at 12:10 CET on February 27, 2023.
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 Pharmaceuticals in brief
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 program 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 Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.
