Immuron (ASX:IMC), a biopharmaceutical company focused on oral immunotherapy utilising polyclonal antibody products to target inflammatory-mediated diseases, has announced that Emory University has enrolled its first patient in its IMM- 124E paediatric NAFLD (Non-Alcoholic Fatty Liver Disease) Phase II trial.
This Phase 2, double blind, placebo-control, randomised study, is designed to assess the safety and efficacy of IMM-124E for the treatment of Paediatric NAFLD.
The study's principal objective is to evaluate whether 12 weeks of IMM-124E treatment in children with confirmed NALFD will decrease serum ALT. The study aims to enrol 40 paediatric patients.
Paediatric NAFLD 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. It is believed to affect up to 5 - 10 per cent of the US paediatric 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 per cent of the children aged 15 to 19 years had NAFLD.
There are currently no treatments approved for the treatment of paediatric NAFLD.
The company said it believes 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 paediatric NAFLD.
According Dr Dan Peres, Immuron’s head of medical, “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 Paediatric NASH and we look forward to the results of this trials to decide on the next stage of the clinical program.”