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

Summary
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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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/190104468
Start date: 01-09-2022
End date: 31-03-2025
Total budget - Public funding: 3 571 428,75 Euro - 2 499 993,00 Euro
Cordis data

Original description

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.

Status

SIGNED

Call topic

HORIZON-EIC-2021-ACCELERATOROPEN-01

Update Date

09-02-2023
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Horizon Europe
HORIZON.3 Innovative Europe
HORIZON.3.1 The European Innovation Council (EIC)
HORIZON.3.1.2 The Accelerator
HORIZON-EIC-2021-ACCELERATOROPEN-01 EIC Accelerator Open 2021