Strong Safety and Tolerability in Phase I Trials for IMU-856 Supports Broad GI Applications

PE: What are the key takeaways from the safety and tolerability data observed in the phase 1/1b trials, and how do these findings support the drug's development for other gastrointestinal diseases?

Vitt: The key takeaway was the fact that it was safe and well tolerated. Meanwhile, the company has completed the chronic studies. That clearly shows us that this drug can be used broadly n different patient populations going forward, and there was nothing specific showing up in the studies which we believe would limit its use from a long-term perspective. I think in GI disorders, you want to have more long-term possibilities for treatments, and you need something that is quite well tolerated.

PE: The trial showed no dose-dependent adverse events or maximum tolerated dose. How does this safety profile influence dosing strategies for future studies?

Vitt: For chronic indications, you typically want to have a benign safety and tolerability profile, and you don’t want to overdose into an area where patients may have severe safety or tolerability issues. Therefore, one would try to not go above a safe region on treatment. To be more specific, we have seen in the Phase I study that 160 milligrams demonstrated effectiveness already. For these specific indications, we don’t think that it needs a higher dose.

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.