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Novel First-in-Class Specific Oromucosal Immunotherapy (SOMIT) to treat Celiac Disease (CD)

Project description

Curing coeliac disease with a mouth patch

Coeliac disease is an autoimmune condition associated with an immune reaction to eating gluten, a protein found in wheat, barley and rye. As there is no cure for coeliac disease, the only management option is a strict gluten-free diet for life. Funded by the European Innovation Council, the SOMIT-CD project aims to develop a novel immunotherapy approach against coeliac disease. The proprietary technology comes in the form of a mouth patch and combines a tolerance-inducing agent and gluten. The idea is to present gluten to immune cells in the oral mucosa and induce tolerance to the protein. The project encompasses the preclinical validation of the approach and a clinical study.

Objective

Celiac disease is an autoimmune indication for which there is no cure. Only the life-long avoidance of the disease causing gliadin protein in gluten is available as a sub-optimal and cumbersome necessity for CD patients. We developed a unique novel combination of antigen (gliadin protein), probiotic tolerogenic bacterial particles (TBPs) and mouth patch technology to enhance the bioavailability and tolerance induction. Synergistic tolerizing properties of the TBP-antigen combination and the therapeutic effect of the SOMIT concept has been shown in a suitable pig model. Our SOMIT-CD promises to require a short-course weekly treatment for less than 3 months in CD patients.
This EIC project will allow us to finalize the various preclinical activities and perform phase Ib/IIa clinical study, paving the way to closing a co-development deal with a big pharma player.
After market entry in 2029, we aim to reach a market share of 15% and generate annual revenues of 148M by 2033.

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Topic(s)

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Funding Scheme

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HORIZON-EIC-ACC-BF - HORIZON EIC Accelerator Blended Finance

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Call for proposal

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(opens in new window) HORIZON-EIC-2021-ACCELERATOROPEN-01

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Coordinator

ALLERO THERAPEUTICS BV
Net EU contribution

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.

€ 2 499 993,00
Address
MARCONISTRAAT 16
3029 AK Rotterdam
Netherlands

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

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.

€ 3 571 428,75
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