Expanding Therapeutic Potential: Advancing IMU-856 Across Several Indications

PE: Given the high unmet needs in gastrointestinal diseases, how is Immunic positioning itself to potentially lead in this therapeutic area, and what role do partnerships or collaborations play in your strategy?

Vitt: There are numerous potential indications for this drug. Celiac disease is the leading candidate, but it could also be effective in Crohn’s disease and ulcerative colitis. This would make it an ideal combination partner for immunosuppressive therapies used in those conditions. Additionally, it may have potential in niche indications such as graft-versus-host disease, broadening its clinical utility.

Our ongoing Phase III program in multiple sclerosis reflects our focus on neuroinflammation. We see two primary areas of impact: neuroprotection and gastrointestinal disorders, both of which are core priorities for our company. This program positions us to establish leadership in both the gastrointestinal and neuroinflammation spaces.

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.