Immunic Inc (NASDAQ:IMUX) announced that data from its Phase 1/1b clinical trial for IMU-856, a small molecule targeting SIRT6, has been published in The Lancet Gastroenterology & Hepatology.
The study, led by Dr James Daveson, a gastroenterologist with Wesley Research Institute in Australia, evaluated IMU-856’s safety and efficacy in patients with celiac disease.
In a statement, Daveson noted that celiac disease affects about 1.4% of the global population, with dietary restrictions as the only available treatment.
“IMU-856's potential ability to improve the integrity and function of the intestinal barrier represents a promising, novel approach to treat this condition,” Daveson said, adding that the trial showed IMU-856 could mitigate gluten-related effects.
IMU-856, developed as an oral, systemically acting SIRT6 modulator, demonstrated promising results across multiple clinical measures. The drug showed improvements over placebo in protecting gut structure, symptom relief, biomarker response, and nutrient absorption in patients on a gluten-free diet as well as during a gluten challenge.
Daniel Vitt, Immunic's CEO, highlighted the potential of IMU-856 to revolutionize gastrointestinal treatment by promoting gut wall renewal. “IMU-856 showed the first clinical signals of its potential to restore a healthy gut," Vitt said, emphasizing the trial's favorable safety and tolerability profile, with no severe adverse events related to the drug.
The Phase 1 trial consisted of three parts, with Parts A and B involving single and multiple ascending dose tests in 71 healthy participants, showing no serious adverse events and no maximum tolerated dose. Part C, conducted in Australia and New Zealand, involved 43 celiac disease patients randomized to receive IMU-856 or placebo during a gluten challenge.
The trial demonstrated the positive effects of IMU-856 on celiac disease symptoms, malabsorption markers, and histological integrity, with a similar safety profile to placebo.
Immunic said that the findings support further clinical investigation of IMU-856 as a potentially first-in-class oral therapy for celiac disease, as well as for other gastrointestinal disorders with significant unmet needs.