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A novel ulcerative colitis treatment - A phase III ready feasibility study

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

InDex Pharmaceuticals AB (InDex) is a pharmaceutical development company based at the Karolinska Institutet campus in Stockholm, Sweden. The company´s primary asset is cobitolimod, which is in late phase clinical development as a new medication to treat moderate to severe active ulcerative colitis (UC); a chronic, debilitating disease with a high unmet medical need. UC is caused by chronic inflammation of the colon, and whilst some treatment is available, there is no cure.
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.
InDex had preliminary identified six activities to be part of this phase III ready program. Those have been tested and/or validated for feasibility. The scope, cost and time of each of the verified activities have also been defined. All six activities have been confirmed to be essential for the phase III ready program and one additional activity has been identified as necessary and should be added to the program.
The activities needed to be performed prior to conducting a Phase III clinical program increasing the attractiveness of the asset in partnering discussions with pharmaceutical companies looking for innovative new products. A licensing deal will ensure that the development of this promising innovative drug will continue in a fast and efficient way to reach patients with this debilitating disease.
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