InDex Pharmaceuticals Holding AB (publ) announced that 30% of patients have completed the final visit in Induction Study 1 of the phase III program CONCLUDE, which is evaluating cobitolimod as a novel treatment for patients with moderate to severe, left-sided ulcerative colitis. The outcome of the cobitolimod dose selection analysis will be presented in Fourth Quarter this year according to plan. Phase III program: Induction Study 1 will include approximately 440 patients and is conducted at several hundred clinics in 30 countries in Europe, the Americas and the Asia-Pacific region.

The CONCLUDE program consists of two sequential induction studies which both feed into a maintenance study with patients who have responded to induction therapy. Each patient remains in the maintenance study for approximately one year. Dose selection analysis: With 30% of patients having completed Induction Study 1, data cleaning, review and analysis will now be finalised and is estimated to take up to 2 months.

An independent Data Monitoring Committee (DMC) will make two recommendations regarding the continuation of the study: Whether or not the study can continue.Which dose of cobitolimod (250 mg or 500 mg) to use for the remainder of the study (assuming continuation). It is important to note that this analysis is blinded to all but the DMC. No efficacy or safety data will be available to InDex, patients, investigators or study personnel.

Patient recruitment into Induction Study 1 continues throughout this analysis.