A promising new approach to treating coeliac disease may offer hope to millions living with the condition.
Early data from a clinical trial of IMU-856, a novel small molecule drug, suggests potential in repairing gut function – an exciting development for those with coeliac disease.
With the clinical study led by Dr James Daveson, Clinical Director of the Coeliac Disease and Immune Health Research Program at WRI, the findings were published this week in The Lancet Gastroenterology & Hepatology.
IMU-856, developed by United States-based Immunic Inc, targets SIRT6, a protein critical for maintaining gut barrier integrity. By promoting gut wall renewal without suppressing the immune system, IMU-856 presents a potentially groundbreaking alternative to the strict gluten-free diet that is currently the only management option for coeliac disease.
“This phase 1b clinical trial is the first study to show that IMU-856 can mitigate the gluten-related effects in coeliac disease patients,” said Dr Daveson, who also works with the Coral Sea Clinical Research Institute in Mackay.
With its potential ability to improve the integrity and function of the intestinal barrier, IMU-856 represents a promising, novel approach to treating this condition.
Dr James Daveson
The trial was conducted at sites in Australia and New Zealand, enrolling coeliac disease patients, including at our very own Clinical Trials Centre at Wesley Research Institute, located in Brisbane, Queensland. We thank all patients who participated in this important clinical trial.
During the study, IMU-856 improved gut architecture, symptoms and nutrient absorption in patients exposed to gluten, while showing a favourable safety profile.
“Based on this result, in conjunction with the drug’s safety and tolerability profile, it is exciting to think this therapy will progress to the next stage of trials”.
These findings indicate that IMU-856 may serve as a viable new treatment not only for coeliac disease but potentially for other gastrointestinal disorders with limited therapeutic options.
Dr James Daveson emphasised the importance of further clinical investigation, as Immunic Inc prepares to advance IMU-856 into phase 2 trials.
The paper is entitled, “Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a novel SIRT6 modulator, in coeliac disease: a first-in-human, randomized, double-blind, placebo-controlled phase 1 trial”.
This innovative study was also featured in The Australian, with Dr James Daveson welcoming back coeliac disease clinical trial patient Kay Roper, to discuss how this phase-one clinical trial could one day help to treat the condition.
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