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PR Newswire
Immunic's Oral IMU-856 Demonstrated Dose-Dependent Increase of GLP-1 in Celiac Disease Patients and Corresponding Effects in Preclinical Testing
PR Newswire
10 min read

In This Article:

– New Data Suggests that IMU-856 Could Be a Potential Oral Treatment Option for Weight Management; Program Is Phase 2 Ready –

– Dose-Dependent Increase of Endogenous GLP-1 Levels Observed in Post Hoc Analysis of Patients From Phase 1b Clinical Trial in Celiac Disease –

– Dose-Dependent Reduction of Body Weight Gain and Food Consumption Observed in Preclinical Study –

– Webcast to be Held Today, February 20 at 8:00 am ET –

NEW YORK, Feb. 20, 2025 /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 that IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from its phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.

"GLP-1, a hormone that occurs naturally in the gut, is released after eating and helps the body regulate blood sugar and satiety. It plays several critical roles, including triggering insulin release from the pancreas and blocking glucagon, a hormone raising blood sugar. Additionally, GLP-1 affects areas of the brain that process hunger and satiety," noted Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic. "IMU-856's target, SIRT6, is highly expressed in cells of the bowel wall, including enteroendocrine cells, which produce gastrointestinal hormones such as GLP-1 and gastric inhibitory peptide (GIP). Our phase 1b clinical trial in celiac disease patients demonstrated IMU-856's ability to regenerate epithelial cells, as measured by protection of villous height and improved cellular function. The current observations of increased GLP-1 in these celiac disease patients and the preclinical signs of reduced body weight gain indicate that IMU-856 may also have the effect of activating the function of enteroendocrine cells. These findings corroborate the tissue renewal effects already seen for IMU-856 and warrant continued evaluation, as they may meaningfully expand the potential indications for IMU-856."

New data is available from a post hoc analysis of the company's phase 1b clinical trial of IMU-856 in celiac disease patients, where blood concentrations of GLP-1 were measured, between baseline and day 28, in a fasting state. A highly statistically significant (day 29: 80 mg p=0.014; 160 mg p=0.003) and dose-dependent increase of GLP-1 versus placebo control was detectable, even in the small patient population in this phase 1b clinical trial (baseline: N placebo = 11, N 80 mg IMU-856 = 13, N 160 mg IMU-856 = 13). These clinical findings were corroborated by effects observed in a 6-month preclinical in vivo study, where IMU-856 was found to reduce body weight gain accompanied by food consumption in a dose-dependent fashion up to -40 %, compared to the control group, which was found to be linked to reduced food intake.

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