Presentation

InDex Pharmaceuticals is a Swedish company focusing on immunological diseases. The company’s lead asset is cobitolimod, which is the first-in-class TLR9 agonist and is being evaluated in a Ph3 study as a novel treatment of moderate to severe ulcerative colitis. The company also has 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 headquartered in Stockholm, Sweden.

Recent highlights
In November, InDex announced that the first patient had been enrolled in the pivotal Ph3 study of cobitolimod for patients with moderate to severe left-sided ulcerative colitis. The study aims to include approximately 440 patients and be conducted in over 30 countries including Europe, the US and the Asia-Pacific region. In December, the company announced the initiation of a clinical pharmacokinetic study to evaluate the systemic uptake of cobitolimod in local treatment of colonic inflammation. In March, InDex announced its plan for self-commercialisation of the drug candidate cobitolimod in the US and strategic collaborations in other regions, with marketing approval and launch expected in 2027.

Outlook
The company’s primary focus is on the implementation of the Ph3 CONCLUDE trial, which will form the basis for marketing approval of cobitolimod in moderate to severe ulcerative colitis. Results from the first Ph3 study are expected H2 2023, and the whole program is expected to be completed in 2026.