Immuron Limited (ASX:IMC) is progressing recruitment for the clinical trial of its fatty liver disease treatment.
Of the 19 sites initiated globally for the Phase 2 trial of IMM-124E, 13 are in the U.S. and six are in Australia.
Three additional site, two in Israel and one in the U.S., are in the process of being initiated, which will bring the total clinical sites to 21 over the coming months.
The study will enrol a total of 120 patients with liver biopsy confirmed Non Alcoholic Steatohepatitis (NASH), a progressive form of non-alcoholic fatty liver disease characterised by fat buildup in the liver and chronic inflammation.
NASH may progress to cirrhosis, liver failure and even cancer. Its prevalence 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. IMM-124E will be compared to placebo in its potential to reduce liver fat and serum liver enzymes.
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. To date 33 patients had been entered into the study with ten continuing on to randomisation and dosing.
Immuron is working closely with its principle investigators and key opinion leaders to develop initiatives to drive recruitment with the aim of having the trial fully recruited by the end of 2015.
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