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

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.