Presentation

Company Profile
InDex Pharmaceuticals is a company focusing on immunological diseases. The firms lead drug candidate is cobitolimod, a Karolinska Institutet originated drug with potential in inflammatory diseases. The drug is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. Cobitolimod has received orphan drug designation (ODD) by the FDA for pediatric use. 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 treatment of various immunological diseases. The company is headquartered in Stockholm, Sweden, and listed on Nasdaq First North.

Recent highlights
In January, InDex carried out a fully guaranteed rights issue of approximately 533 SEKm. In March, the company announced that it entered an agreement with the CRO Parexel Biotech for the phase III clinical study of cobitolimod for ulcerative colitis. In May, the company announced that patient recruitment for the phase III study CONCLUDE is planned to initiate after the summer. The study will evaluate the efficacy and safety of the drug candidate cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis. In July, the company announced that the Swedish Medical Products Agency (MPA) has given approval to start the phase III clinical study CONCLUDE in Sweden.

Outlook
The company’s primary focus is now the Phase III CONCLUDE trial. The study is expected to include 440 patients in over 30 countries, and it will have an induction part and a maintenance part, with 6 weeks and 1 year follow-up respectively.