New Clinical Trial for Celiac Disease

Immunic, Inc. today announced the start of the patient cohorts in its ongoing phase 1 clinical trial of IMU-856, the company’s third clinical asset, in patients with celiac disease.

IMU-856 is an orally available and systemically acting small molecule modulator that targets an undisclosed epigenetic regulator. Preclinical studies suggest that IMU-856 can restore barrier function in the gastrointestinal tract and also regenerate intestinal architecture while maintaining immunocompetency. Based on preclinical and early clinical data available to date, the company believes that IMU-856 may represent a novel and potentially ground-breaking approach to the treatment of gastrointestinal diseases.

“Start of Part C of this phase 1 clinical trial in celiac disease patients marks an important milestone in the clinical development of IMU-856, and we hope to be able to confirm its ability to restore intestinal barrier function without affecting the immune system,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Because it represents a significant unmet need with well characterized surrogate markers of disease activity, we believe that celiac disease is an ideal initial clinical indication to provide proof-of-concept of IMU-856’s acute and chronic impact. IMU-856’s mechanism could present an entirely new approach to treat a significant number of serious and widely prevalent gastrointestinal diseases, and we believe it could offer a clinical benefit without the serious consequences associated with many autoimmune therapies. Moreover, we look forward to providing the full safety data set from the single and multiple ascending dose portions of this ongoing phase 1 clinical trial in healthy human subjects, currently expected to be available in the third quarter of this year.”

“Celiac disease is a life-long and serious autoimmune disease of the small bowel whose pathophysiology is due to gluten-induced damage to the intestinal barrier. Despite adhering to a gluten-free diet, many patients experience ongoing disease activity which may lead to chronic diarrhea, abdominal pain, malabsorption of nutrients and even increased risk of anemia, osteoporosis and certain cancers,” stated Andreas Muehler, M.D., Chief Medical Officer of Immunic. “There is an immense need for an effective therapeutic intervention for patients with celiac disease, as the only therapeutic approach today is a strict, life-long gluten-free diet, which is burdensome, often socially restrictive, and regularly fails to stop disease activity. In light of IMU-856’s potential to restore intestinal barrier function and intestinal architecture, we believe this compound holds particular promise in improving patients’ gastrointestinal health and ability to digest and properly absorb nutrients, thereby reducing possible long-term consequences and improving their quality of life, disease symptoms and potential future complications.”

Parts A and B of the ongoing phase 1 clinical trial are evaluating single and multiple ascending doses of IMU-856 in healthy human subjects. The now initiated Part C is structured as a 28-day, double-blind, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge. Approximately 42 patients are planned to be enrolled in two consecutive cohorts with IMU-856 given once-daily over 28 days. Secondary objectives include pharmacokinetics and disease markers, including those evaluating gastrointestinal architecture and inflammation. Approximately 10 sites in Australia and New Zealand are expected to participate in Part C.

The company also reiterates its prior guidance that phase 2 top-line data of vidofludimus calcium (IMU 838) in ulcerative colitis is expected to be available in June of 2022 and that initial clinical efficacy data of the Part C portion of the ongoing phase 1 clinical trial of IMU-935 in psoriasis is expected in the second half of 2022.