Slide 1: IMU-856 Showed Positive Effects on Gut Hormone Levels in Celiac Disease Patients
IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration, Showed Positive Effects on Gut Hormone Levels in Celiac Disease Patients in a Phase 1 Clinical Study Amelie Schreieck1, Indira Pichetto Olanda1, Doris Pröbstl2, Evelyn Peelen1, Juliano Fonseca1, Martina Wirth 1, Sara Elhag1,
Slide 2: Disclosure of Conflicts of Interest
Disclosure of Conflicts of Interest I herewith declare the following paid or unpaid consultancies, business interests, or sources of honoraria payments for the past three years, and anything else which could potentially be viewed as a conflict of interest: I am an employee of Immunic AG and own sha
Slide 3: Disclaimer - Forward-Looking Statements
Disclaimer - Forward-Looking Statements 3 | © Immunic, Inc. | October 4-7, 2025 | UEG Week Berlin 2025 | IMU-856 is an investigational drug; not approved for commercial use.
Slide 4: Mode of Action of IMU-856
Mode of Action of IMU-856 • IMU-856 is a highly selective and potent modulator of epithelium the enzymatic activity and stability of SIRT6 (sirtuin 6) Ac Protein + NAD+ • IMU-856 promotes intestinal regeneration and improves Regeneration barrier function in human cell and animal models SIRT6 IMU-85
Slide 5: SIRT6 is Highly Expressed in Intestinal Epithelial Cells Including All Secretory Cell Types
SIRT6 is Highly Expressed in Intestinal Epithelial Cells Including All Secretory Cell Types Duodenal biopsy of celiac disease patient Highest mRNA Expressions in Paneth Cells, Enterocytes, Goblet Cells and Enteroendocrine Cells such as L-Cells Left: https://www.proteinatlas.org/ / Right: Peterson, L
Slide 6: Phase 1b Clinical Trial of IMU-856 Designed as a Gluten Challenge Trial
Phase 1b Clinical Trial of IMU-856 in Celiac Disease Designed as a Gluten Challenge Trial • Population of well-controlled celiac disease patients with gluten challenge of 6 g/day for 15 days • Dosing: 80 and 160 mg PO once daily of IMU-856 • N=43 (IMU-856 80 mg: N=14, IMU-856 160 mg: N=15) • Proof o
Slide 7: IMU-856 Protected Against Gluten-Induced Decrease in Villous Height as Compared to Placebo
IMU-856 Protected Against Gluten-Induced Decrease in Villous Height as Compared to Placebo • Substantial protection for IMU-856 treatment groups as compared to placebo • Reached statistical significance* • Assessed by central pathology laboratory and blinded pathology reader * Wilcoxon Two-Sample Te
Slide 8: IMU-856 Showed Signal for Improved Enterocyte Mass and Function
IMU-856 Showed Signal for Improved Enterocyte Mass and Function • Citrulline is a biomarker for enterocyte functional mass[1] • Plasma citrulline levels are known to correlate with villous atrophy • IMU-856 increased citrulline levels dose proportionally before gluten challenge, whereas levels were
Slide 9: IMU-856 Treatment Resulted in Dose Linear Enhanced Uptake of Vitamin B12 and Zinc
IMU-856 Treatment Resulted in Dose Linear Enhanced Uptake of Actively Transported Essential Nutrients Vitamin B12 and Zinc 9 | © Immunic, Inc. | October 4-7, 2025 | UEG Week Berlin 2025 | IMU-856 is an investigational drug; not approved for commercial use.
Slide 10: IMU-856 Substantially Increased GLP-1 in Celiac Disease Patients
IMU-856 Substantially Increased GLP-1 in Celiac Disease Patients GLP-1 • Peptide hormone secreted in response to nutrient ingestion and neuroendocrine stimulation • GLP-1 increase leads to slow gut motility, lower food intake, increase satiety and induce insulin secretion • Patients measured for pla
Slide 11: IMU-856 – From Proof of Concept in Celiac Disease to IBD and Beyond
IMU-856 – From Proof of Concept in Celiac Disease to IBD and Beyond Enterocytes • Regenerates gut barrier (cell renewal / differentiation) • Drives gut barrier tightness (via tight junction proteins) Enteroendocrine cells • Increases GLP-1 hormone secretion GLP-1 →influence on gastric emptying →anti