Immunic Inc (NASDAQ:IMUX) Chief Medical Officer Dr. Andreas Muehler talked with Proactive about the publication of the company’s Phase 1 and Phase 1b clinical trial results for IMU-856 in The Lancet Gastroenterology & Hepatology. Dr. Muehler highlighted the company’s excitement regarding the publication, underscoring how it validates the significance of IMU-856’s clinical data for the medical field. He expressed gratitude to the authors, investigators, and patients involved in this trial, acknowledging their roles in achieving this milestone.
Proactive: Could you give us a summary of the Phase 1 data in healthy volunteers, Andreas?
Dr. Andreas Muehler: Yes. The publication covers the complete Phase 1 study conducted in Australia and New Zealand, divided into three parts. Part A and B used healthy volunteers to test single and multiple doses, increasing step-by-step to explore safety and pharmacokinetics—basically how the drug distributes and is excreted in the body. We found the drug was very well tolerated, with no general increase in adverse events or lab abnormalities linked to higher doses. Additionally, pharmacokinetics showed good oral absorption, with a half-life of around 20 hours, suggesting a convenient once-daily dosing.
How about the Phase 1b data in celiac disease patients, Andreas?
Yes, this phase was unique as not many biotechs and pharma companies look into the therapeutic window within Phase 1. We targeted patients with celiac disease in Part C, allowing us to assess how IMU-856 could function within an actual disease context. Celiac disease is a very underserved population with no approved treatment, so it was important to test for proof of concept here. Using a gluten challenge, we could measure the drug’s effectiveness in managing symptoms and preserving gut health during a short, 28-day dosing. The data allowed us to observe IMU-856’s potential for protecting and even improving epithelial health in the gut.
Could you provide a quick summary of the mode of action of IMU-856?
IMU-856 has a unique approach; instead of affecting the immune system directly, it promotes epithelial regeneration in the bowel. In our view, this sets it apart from immunosuppressive drugs, which can have long-term consequences for patients. By stimulating natural epithelial renewal, it strengthens the gut barrier without the side effects linked to immune modulation. We've observed in preclinical and clinical data that it strengthens the gut’s barrier function, a critical component in celiac and potentially other gastrointestinal diseases.
What potential do you see for other gastrointestinal diseases?
The bowel barrier and epithelial architecture are crucial for many gastrointestinal diseases, so we’re considering extending IMU-856’s application beyond celiac disease. We see potential for conditions like inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s) and other diseases driven by bowel barrier issues, such as diarrhea-predominant IBS. Expanding into these areas could fully explore IMU-856’s mechanism of action, and we hope the publication of our data in The Lancet will help advance these goals.
Congratulations again on the publication. Thank you for speaking with us today.
Thank you.
Quotes have been lightly edited for style and clarity