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E40-02 is a recombinant gluten-degrading enzyme being developed by Enteralia Bioscience (formerly Nemysis) for the treatment of celiac disease. As a second-generation candidate following the company's lead asset E40-01, E40-02 is designed to function as a prolyl endopeptidase (PEP) that remains stable and active within the acidic environment of the stomach. The drug's mechanism of action involves the enzymatic cleavage of immunogenic gluten peptides—specifically those rich in proline and glutamine residues—which are typically resistant to human gastrointestinal proteases. By breaking down these peptides into smaller, non-immunogenic fragments before they reach the small intestine, E40-02 aims to mitigate the autoimmune response and subsequent mucosal damage triggered by accidental gluten ingestion in individuals with celiac disease. The asset is currently in Phase 1 clinical development.
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