Immunic, Inc.'s oral small molecule therapy IMU-856 has demonstrated promising results in increasing GLP-1 levels and potentially managing weight, according to new data from a Phase 1b clinical trial and preclinical studies. The findings suggest a novel approach to weight management through oral administration, potentially addressing a market expected to reach $170 billion globally by 2031.
Clinical Trial Results Show Significant GLP-1 Increase
Post hoc analysis of the Phase 1b trial in celiac disease patients revealed a highly statistically significant and dose-dependent increase in GLP-1 levels. Patients receiving IMU-856 showed GLP-1 increases of up to 250% compared to placebo, measured under fasting conditions over 28 days. The statistical significance was particularly strong for both dosage groups (80 mg: p=0.014; 160 mg: p=0.003).
Mechanism of Action and Hormonal Effects
IMU-856 functions as a modulator of SIRT6 (Sirtuin 6), which is highly expressed in bowel wall cells, including enteroendocrine cells responsible for producing gastrointestinal hormones. Dr. Hella Kohlhof, Chief Scientific Officer of Immunic, explained that GLP-1's natural role includes regulating blood sugar, triggering insulin release, and influencing hunger and satiety signals in the brain.
Preclinical Evidence Supports Weight Management Potential
Supporting the clinical findings, a 6-month preclinical study demonstrated IMU-856's ability to reduce body weight gain and food consumption in a dose-dependent manner. The study showed reductions of up to 40% compared to control groups, correlating with decreased food intake.
Advantages Over Current Treatments
"While currently available incretin mimetics delivered via subcutaneous injection focus on one or two enteroendocrine hormones, we hypothesize that the SIRT6 modulation approach may result in a broader, more physiologic activation of enteroendocrine hormones," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. This suggests IMU-856 could offer a more comprehensive and natural approach to weight management.
Development Status and Future Plans
The program is now Phase 2-ready, with Immunic preparing for further clinical testing. The company plans to explore the broader implications of SIRT6 modulation and its effects on enteroendocrine hormone activation. The development of IMU-856 as an oral treatment option could provide a more convenient alternative to current injectable therapies for weight management.
Safety and Additional Benefits
Initial data suggests IMU-856 maintains immune surveillance during therapy, potentially offering an advantage over immunosuppressive medications. The drug has also shown positive effects on intestinal barrier function and bowel wall architecture, indicating possible applications in various gastrointestinal diseases.
