Melbourne-based Immuron (ASX: IMC) has announced progress in recruitment for its Phase 2 clinical trial for IMM-124E in the treatment of NASH (Non Alcoholic Steatohepatitis).
The company said 19 sites have been initiated, with 13 in the US and six in Australia. A further three sites are in the process of being initiated, with 2 in Israel and an additional site in the US.
NASH is a progressive form of non-alcoholic fatty liver disease (NAFLD) characterised by fat build-up in the liver and chronic inflammation. It can progress to cirrhosis, liver failure and even cancer.
The company said the prevalence of NASH is increasing globally, associated with rising obesity, dyslipidemia and type 2 diabetes.
The primary objectives of the study are to evaluate the safety and preliminary efficacy of IMM-124E. It will be compared to placebo in its potential to reduce liver fat and serum liver enzymes.
"The study will enrol a total of 120 patients with liver biopsy confirmed NASH," the company said. "Patients randomised into the study will be orally administered either 600mg or 1,200mg doses of the study drug IMM-124E or placebo 3 times daily for 6 months."
According to Dr Dan Peres, Senior Vice President of Innovation, "We have established an impressive network of world-leading investigators, and now we expect to see an acceleration in recruitment."