IMU-856: A Potential Solution for Celiac Patients Facing Cross-Contamination Risks

PE: How do you envision IMU-856 addressing the challenges of gluten-free diets and cross-contamination risks for celiac disease patients?

Vitt: If you consider the mode of action, the advantage of this approach is that it could work in all patients, even those with more severe disease, because the biggest problem is usually cross-contamination or exposure to very small amounts of gluten. Therefore, the key target population for treatment with IMU-856 includes patients with ongoing, active celiac disease, particularly those at risk of reacting to trace amounts of gluten. A strength of this concept is that it may even be effective in patients with very severe celiac disease.

Full Interview Summary: The Phase Ib trial of IMU-856 demonstrated improvements across multiple endpoints, including histology, symptoms, biomarkers, and nutrient absorption. Among these, the most critical finding for advancing the drug to later-stage trials is its ability to restore the gut’s epithelial layer without immunosuppression. The drug achieved statistically significant histologic protection, even with a small patient sample, indicating its potential to preserve gut integrity. Additionally, functional improvements, such as increased vitamin B12 uptake despite gluten exposure, highlight its unique mode of action and rapid onset of efficacy.

IMU-856 offers a promising solution for celiac disease patients, particularly those at risk of symptom flare-ups due to cross-contamination with small amounts of gluten. By strengthening the gut barrier, the drug could benefit patients with active and severe disease, who often struggle with inadvertent gluten exposure.

Regarding safety and tolerability, the trial found IMU-856 to be well tolerated with no dose-dependent adverse events or maximum tolerated dose concerns. Chronic toxicology studies have also confirmed its potential for long-term use across various gastrointestinal disorders. The favorable safety profile allows for flexible dosing strategies, with the 160 mg dose already showing strong efficacy. Future studies may explore slight adjustments in dosage to optimize treatment.

With ongoing Phase III programs in neuroinflammation and multiple sclerosis, Immunic aims to establish itself at the forefront of both gastrointestinal and neuroinflammatory diseases. Collaborations and strategic partnerships will likely play a key role in expanding the drug’s applications.