Immunic Reports Positive Phase 1 Results for Celiac Disease Therapy Published in The Lancet

Promising Findings for Celiac Disease Sufferers

Immunic, Inc., a clinical-stage biotechnology company, has announced positive Phase 1 results for its investigational celiac disease therapy, IMU-838. The findings were published in the prestigious medical journal The Lancet. This is a significant milestone in the development of a potential treatment for celiac disease, a chronic autoimmune disorder that affects millions worldwide.

Key Findings of the Phase 1 Study

The Phase 1 study evaluated the safety, tolerability, and preliminary efficacy of IMU-838 in patients with celiac disease. The study included 32 participants who received either a single dose or multiple doses of IMU-838. The results showed that IMU-838 was well-tolerated, with no serious adverse events reported.

In terms of efficacy, IMU-838 demonstrated promising results. Patients who received multiple doses of IMU-838 showed a significant reduction in intestinal inflammation, a key indicator of celiac disease activity. Additionally, patients reported improvements in their gastrointestinal symptoms, such as abdominal pain, diarrhea, and bloating.

Mechanism of Action

IMU-838 is a fully human monoclonal antibody that targets the alpha-4 integrin, a protein expressed on immune cells involved in celiac disease. By blocking the interaction between alpha-4 integrin and its ligands, IMU-838 inhibits the activation and migration of these immune cells into the gut, thereby reducing inflammation.

Next Steps in Development

The positive Phase 1 results for IMU-838 provide a strong foundation for further clinical development. Immunic plans to initiate a Phase 2b clinical trial in patients with celiac disease later this year. The Phase 2b trial will evaluate the efficacy and safety of IMU-838 over a longer period of time and in a larger population of patients.

If the Phase 2b trial is successful, Immunic will move on to Phase 3 trials to confirm the efficacy and safety of IMU-838 and seek regulatory approval for the treatment of celiac disease.

Conclusion

The positive Phase 1 results for IMU-838 are a significant step forward in the development of a potential treatment for celiac disease. The findings provide hope for millions of people who suffer from this debilitating condition. Further clinical trials are needed to confirm the efficacy and safety of IMU-838, but these early results are promising.