A new and unique mechanism of action
Cobitolimod is part of InDex Pharmaceuticals’ DNA-based ImmunoModulatory Sequence (DIMS) platform. It is administered locally in the large intestine, where the substance binds to Toll-like receptor 9 (TLR9) present inside immune cells as well as on the surface of epithelial cells. The binding triggers the cells to product anti-inflammatory cytokines, agents that play an important role in reducing inflammation and healing the wounds in the large intestine caused by UC.
Clinical studies evaluating cobitolimod have shown a competitive clinical effect in treating ulcerative colitis combined with a superior safety profile. It has an excellent safety profile, which is in contrast to many of the current treatments that weaken the immune system and are therefore associated with serious side effects such as infections and cancer. InDex Pharmaceuticals is now preparing for upcoming Phase III clinical trials. Click here to find out more.
Our most recent completed clinical trial with cobitolimod
InDex’s most recent clinical trial evaluating cobitolimod in ulcerative colitis – the phase IIb trial CONDUCT – showed that the highest dose of cobitolimod given to patients, 2 x 250mg, met the study’s primary endpoint with a clinically relevant and statistically significant effect (compared with placebo) combined with an excellent safety profile.
In line with EMA and FDA guidelines for what primary endpoint they require in clinical studies in order for a Phase III drug candidate to obtain market approval, the primary endpoint for the CONDUCT study was a certain score determined by three parts: 1) blood in the patient’s stool, 2) stool frequency, 3) the level of inflammation in the intestine when examining the mucosa with a camera during colonoscopy. It was precisely this endpoint that was met in the CONDUCT study.
In addition to meeting the primary endpoint of induction of clinical remission at week 6, several secondary endpoints demonstrated statistically significant effects in the 2x250mg dose group compared to placebo. Read more about these secondary endpoints here.