Immunic Presents Data From Phase 1b Clinical Trial of IMU-856 in Celiac Disease at the United European Gastroenterology Week 2023

Immunic, Inc., a biotechnology company focused on developing small molecule therapies for chronic inflammatory and autoimmune diseases, recently presented positive data from its phase 1b clinical trial of IMU-856 at the United European Gastroenterology Week (UEGW) 2023 in Copenhagen. IMU-856 is an orally administered small molecule modulator that targets SIRT6, a protein involved in intestinal barrier function and bowel epithelium regeneration.

The trial, which was double-blind, randomized, and placebo-controlled, demonstrated that IMU-856 exhibited significant positive effects over placebo in four key dimensions of clinical outcome in patients with celiac disease. These dimensions included the protection of gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. Importantly, IMU-856 was found to be safe and well-tolerated, with no significant adverse events reported.

Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, expressed his delight at the recognition received by the UEGW for the IMU-856 poster. He highlighted that the phase 1b trial results showed promising clinical signals of IMU-856’s potential to restore a healthy gut in patients with celiac disease. The positive outcomes observed across histology, disease symptoms, biomarkers, and nutrient absorption, along with the drug’s favorable safety profile, suggest that IMU-856 could become a first-in-class oral therapy for celiac disease. Additionally, Dr. Vitt mentioned the potential of IMU-856 to address other gastrointestinal diseases with high unmet needs, such as ulcerative colitis, Crohn’s disease, and irritable bowel syndrome with diarrhea.

IMU-856, which specifically targets SIRT6, aims to restore intestinal barrier function and regenerate bowel epithelium. This mechanism of action makes it a unique treatment approach for gastrointestinal diseases like celiac disease, inflammatory bowel disease, and irritable bowel syndrome with diarrhea. Notably, IMU-856 avoids suppressing immune cells, potentially allowing patients to maintain immune surveillance during therapy, which is a significant advantage compared to immunosuppressive medications.

The positive results from the phase 1b trial have paved the way for Immunic to prepare for phase 2 clinical testing in patients with celiac disease. IMU-856 is an investigational drug product and has not yet received approval in any jurisdiction.

Immunic, Inc. is a biotechnology company dedicated to developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently undergoing phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively. Vidofludimus calcium has also shown therapeutic activity in phase 2 trials for relapsing-remitting multiple sclerosis and moderate-to-severe ulcerative colitis. Immunic’s pipeline also includes IMU-381, a next-generation molecule being developed to address the needs of gastrointestinal diseases.

Overall, Immunic’s commitment to developing innovative therapies for chronic inflammatory and autoimmune diseases, as demonstrated by the positive results from the phase 1b trial of IMU-856, highlights the company’s potential to make a significant impact in improving patient outcomes and addressing unmet medical needs.