Project description
A biological drug for ulcerative colitis
Ulcerative colitis (UC) is associated with long-term inflammation in the colon, causing abdominal pain and diarrhoea. The EU-funded UCRxF project proposes cobitolimod, a novel DNA-based medication for UC, which has a novel mechanism of action and activates the Toll-like receptor 9 (TLR9). The downstream effects of TLR9 activation include ulcer healing and reduction of mucosal inflammation, while initial results from clinical trials are encouraging with respect to the safety and efficacy of cobitolimod. The activities of UCRxF include toxicology evaluation of the drug and improvement in manufacturing prior to proceeding to phase III clinical testing.
Objective
InDex Pharmaceuticals AB is a pharmaceutical development company based at the Karolinska Institutet Science Park 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 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 what has been reported for currently approved biological drugs. Cobitolimod is part of the broad InDex portfolio of DNA-based ImmunoModulatory Sequences (referred to as DIMS), which have the potential for treatment of various immunological diseases. Cobitolimod is currently being tested in a phase IIb clinical study with top line results expected in Q4 2018.
InDex’s business strategy is to out-license cobitolimod to a larger international pharmaceutical company prior to the initiation of clinical phase III development. This will generate revenues for InDex from upfront and milestone payments as well as royalties from third party sales, which can then be reinvested in the company to finance development of new compounds from the DIMS technology platform.
For clinical phase III, additional manufacturing and toxicology work as well as commercial preparations are essential. The planning and preparation of this work is the purpose of this feasibility study, which is a crucial part of the cobitolimod phase III ready programme, 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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- medical and health sciences clinical medicine gastroenterology inflammatory bowel disease
- medical and health sciences basic medicine toxicology
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
MAIN PROGRAMME
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H2020-EU.3. - PRIORITY 'Societal challenges
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H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
SME-1 - SME instrument phase 1
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-EIC-SMEInst-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
171 77 STOCKHOLM
Sweden
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.