IMU-856 Shows Promise in Celiac Disease: Histologic Protection and Nutrient Absorption Key to Advancing Trials

PE: The phase Ib trial demonstrated improvements in histology, symptoms, biomarkers, and nutrient absorption. Which of these findings do you consider most critical for advancing IMU-856 to later-stage trials?

Vitt: IMU-856 is quite unique for GI indications, including celiac disease because it is not immunosuppressive, but it’s able to establish the proper epithelial layer in the gut wall. Therefore, the histologic protection, which even achieves statistical significance by the very small number of patients involved here. The key endpoint is protecting the gut from histologic distraction. It’s also important for the development.

The second important endpoint is the functional improvement. I think this is something new and so far, not seen with other drugs or concepts, because if you restore the proper layer of cells there, then you also have more viable cells.

These cells are actively transporting nutrients from the gut wall into the body. For example, one of the functional endpoints was vitamin B12 uptake. We could see that in the patients during the four weeks of treatment that despite receiving gluten and the gluten challenge, there was an improvement in the dose dependent fashion, which we think speaks for the speed and the quality of an onset of action for the driver.

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.

Immunic is positioning itself as a leader in gastrointestinal therapeutics, with celiac disease as the lead indication for IMU-856. However, the drug’s potential extends to conditions like Crohn’s disease, ulcerative colitis, and graft-versus-host disease. It could serve as a combination therapy alongside immunosuppressants in these conditions. With ongoing Phase III programs in neuroinflammation and multiple sclerosis, the company 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.