The SOMIT-CD project has been set up to bring an immunotherapy for celiac disease into a First-in-Human (FIH) clinical study. The immunotherapy product to be tested in the project is an oral mucoadhesive patch to be applied to the buccal mucosa in the oral cavity. This SOMIT-CD patch consists of two layers, one layer is mucoadhesive and dissolvable. The mucoadhesive layer contains the active components, a gluten peptide and a tolerizing component (the Drug Substances). The other layer covers the mucoadhesive layer and prevents leakage and washing away of the active components in the oral cavity. The SOMIT-CD patch releases its content within about 30 min and is taken up by the oromucosa to initiate a tolerizing process through the draining lymph nodes of the oral cavity.
In the first year of the project we have completed the manufacturing scaling up and TOX batch productions of the two Drug Substances (DSs) and two Drug Products (DPs), being SOMIT-CD and placebo patches. In addition, QC assays were developed and put in place, which resulted in 4 Bill of Tests (BoTs) to properly release the DSs and DPs with signed Certificates of Analyses (CoAs). The developed QC tests are also used to monitor the stability of the 2 DSs and 2 DPs, and these stability studies are ongoing. In a scientific advice with the Swedish regulatory body MPA, confirmation was obtained that the QC release testing and stability testing strategies for the DSs and DPs are compliant with the phase of development.
Moreover, in this period we determined the clinical doses by executing a dose finding study in animals as planned. Based on this we examined the maximum SOMIT-CD dose in a preclinical safety study using the SOMIT-CD and placebo batches. This study in animals showed that no tolerability and safety issues are to be expected for the maximum SOMIT-CD dose level to be used in humans.
In the Q1-Q2 of the second year of the project we will finalize assay and process validation and complete the clinical GMP manufacturing. After submission of the clinical trial application and obtaining regulatory approvals the First-in-Human SOMIT-CD Phase I clinical trial in celiac disease patients is expected to be initiated in Q3 of the second project year.
