This Phase II, double blind, randomized study is designed to assess the safety and efficacy of Immuron’s IMM-124E for the treatment of paediatric NAFLD.
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.
IMM-124E works upstream, and on several pathways, to reduce liver inflammation and is a unique treatment option compared to other leading investigational agents.
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 enrol 40 paediatric patients.
Paediatric NAFLD is believed to affect up to 5% - 10% of the U.S. paediatric population.
A U.S. landmark study that examined the incidence of the disease in 742 children found that 17.3% of children aged 15 to 19 years had NAFLD.
There are currently no treatments approved for paediatric NAFLD.
Immuron’s share price has increased about 11% since the start of 2017, last trading at $0.30.