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Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders
– Positive Effects Demonstrated Over Placebo in Four Key Dimensions of Celiac Disease Pathophysiology: Protection of Gut Architecture, Improvement of
About this update from Immunic, Inc.
[{"type":"text","content":"– Positive Effects Demonstrated Over Placebo in Four Key Dimensions of Celiac Disease Pathophysiology: Protection of Gut Architecture, Improvement of Patients' Symptoms, Biomarker Response, and Enhancement of Nutrient Absorption –\n– Corroborates Hypothesized Ability of IMU-856 to Renew Gut Wall and Restore Gut Health –\n– No Safety or Tolerability Issues Detected –\n– Conference Call and Webcast to be Held Today, May 4, 2023 at 8:00 am ET –\nNEW YORK, May 4, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced positive results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease. The company believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.\nData from four key dimensions of celiac disease pathophysiology and outcomes are summarized as follows:\nProtection of gut architecture and reduction of gluten-induced intestinal damage: Over the course of the trial, the placebo group (N=11) experienced a 60.3 μm reduction in villous height in response to four weeks of treatment and two weeks of 6 g/day gluten challenge. In contrast, this reduction was only 20.9 μm and 22.5 μm for the 80 mg (N=11) and 160 mg (N=13) IMU-856 groups, respectively (p=0.04*). Villi are small finger-like projections found in the lumen of the small intestine, which play a key role in the absorption of digested nutrients necessary for health and growth. Decrease in villous height is a well-recognized measure of gluten-induced damage in celiac disease and a main reason for signs and symptoms of malabsorption. Of particular interest, during the course of the trial, two IMU-856 treated patients demonstrated a 1-category improvement in Q-Marsh histology scores despite 15 consecutive days of exposure to gluten challenge. No analogous improvement was seen with placebo treatment.Improvement of patients' symptoms related to gluten exposure: On the first day of gluten challenge, the placebo group (N=12) experienced a marked average increase in symptoms, as assessed by the Celiac Disease Symptom Diary using a 5-point scale, of 0...