Periodic Reporting for period 1 - UCRxF (A novel ulcerative colitis treatment - A phase III ready feasibility study)
Reporting period: 2018-05-01 to 2018-08-31
Cobitolimod offers a novel and unique mechanism of action for the treatment of UC, and has demonstrated a higher efficacy and better safety profile in clinical studies than has been reported for currently approved biological drugs. Cobitolimod is currently being tested in a phase IIb clinical study with top line results expected during the first half of 2019. Cobitolimod is part of the broad InDex portfolio of more than 150 DNA-based ImmunoModulatory Sequences (referred to as DIMS). Several of the other DIMS have shown potent anti-inflammatory effects both in vitro and in animal models of inflammation. To expand the company’s therapeutic portfolio, InDex has selected some DIMS for further pre-clinical development to leverage the experience, expertise and knowledge gained through the development of cobitolimod. For phase III, additional manufacturing and toxicology work as well as commercial preparations for cobitolimod are essential and will increase the attractiveness of the asset in partnering discussions with pharmaceutical companies looking for innovative new products. The planning and preparation of these activities was the purpose of this feasibility study.