This NIH-funded Phase II, double blind, placebo control, randomized study, is designed to assess the safety and efficacy of IMM-124E for the treatment of Pediatric NAFLD. The principal objective of this study is to evaluate whether 12 weeks of IMM-124E treatment in children with confirmed NALFD will decrease serum ALT. The study aims to enroll 40 pediatric patients.
Pediatric NAFLD (Non-Alcoholic Fatty Liver Disease) is a progressive form of liver disease associated with excessive fat storage in the liver together with inflammation, which can then lead to liver fibrosis and cirrhosis. Pediatric NAFLD is believed to affect up to 5% - 10% of the US pediatric population. A US landmark study that examined the incidence of disease in 742 autopsy children who had died of an accident, found that 17.3% of the children aged 15 to 19 years had Non-Alcoholic Fatty Live Disease (NAFLD). There are currently no treatments approved for the treatment of pediatric NAFLD.
In previous studies conducted by Emory University, it was demonstrated that children with NAFLD have endotoxemia as well as systemic inflammation. Further, patients with NAFLD have a disturbed microbiome (dysbiosis) and increased gut permeability. Thus, the mechanism of NAFLD is thought to include chronic inflammation from intestinal microbiome-derived products (lipopolysaccharide (LPS) and metabolites) which pass through the "leaky gut" to the liver where they activate the innate immune response. We believe that IMM-124E, which is rich in anti-LPS antibodies, will improve insulin resistance and decrease systemic and hepatic inflammation through modulation of bacterial products and the microbiome in pediatric NAFLD.
Dr Dan Peres, Immuron's Head of Medical, commented:
"We would like to thank Emory University and Dr Miram Vos' team for partnering with Immuron on this very important trial. As we highlighted, there are no treatments approved for Pediatric NASH and we look forward to the results of this trials to decide on the next stage of the clinical program."
About Immuron Limited
Immuron Limited (ASX:IMC) (OTCMKTS:IMROY) is a microbiome company focused on developing and commercialising oral immunotherapeutics for the treatment of a many gut mediated diseases. Immuron has a unique and safe technology platform that enables a shorter development therapeutic cycle. The Company currently markets and sells Travelan(R) for the prevention of travellers' diarrhoea, whilst its lead product candidate IMM-124E is in Phase 2b clinical trials for NASH and ASH. These products together with the Company's other preclinical immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in the market.
For more information visit: Immuron Website