Immunic announces publication of IMU-856 data

Immunic (IMUX) announced that the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6, has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. The first two portions of the phase 1 clinical trial, Parts A and B, were single ascending dose and multiple ascending dose, double-blind, placebo-controlled studies in a total of 71 healthy human subjects. Single and multiple ascending doses of IMU-856 were found to be safe and well-tolerated, with no investigational medicinal product-related serious or severe treatment-emergent adverse events. No maximum tolerated dose was reached in either part. Part C was structured as a double-blind, randomized, 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 a 15-day gluten challenge with six grams of gluten given daily. Further objectives included pharmacokinetics and initial clinical activity assessments, including malabsorption parameters, biomarkers for enterocyte functional mass, such as citrulline, disease-related symptoms as well as histological changes. The trial was conducted at sites in Australia and New Zealand. A total of 43 patients were enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 or placebo given once-daily over 28 days. The data demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. There were no IMP-related serious or severe treatment-emergent adverse events, nor was there any dose-dependency in adverse events. Moreover, the rates of treatment-emergent adverse events in non-disease-related parameters were comparable between the active treatment groups and placebo.