Immuron begins patient recruitment for Phase 2 clinical trial of IMM-124E NASH drug candidate

Australian biopharmaceutical company Immuron Limited (ASX: IMC) has today announced a significant milestone in its Phase 2 clinical trial for non-alcoholic steatohepatitis (NASH) with the recruitment of its first two patients at Duke University in the United States. It is expected that further recruitment at Duke and other sites in the US and Australia will follow in early course.

Immuron’s NASH trial is designed as a 120 patient double-blind, placebo-controlled multi-centre and dose ranging study designed to demonstrate that Immuron’s IMM-124E NASH drug candidate based on its hyperimmune colostrum technology improves certain clinical indicators of NASH.

NASH is a chronic inflammatory disorder of the liver which is believed to afflict more than five percent (5%) of the US population. It develops as a second-stage condition in people with non-alcoholic fatty liver (NAFLD) which is believed to afflict more than twenty five percent (25%) of the US population and is highly correlated with obesity, diabetes and hypertriglyceridemia.

US Investigator, Dr. Manal Abdelmalek said:

I am pleased to be leading Immuron’s IMM-124E Phase II clinical trials at Duke University. We are intent on recruiting up to 20 NASH patients over the next few months in this important clinical trial. Once enrolled, screened and randomized, each patient will be treated for 6 months with IMM-124E.

Immuron Chariman of the Board of the Directors, Dr. Roger Aston said:

The recruitment of our first patients in this important clinical trial for Immuron and people who suffer from NASH is an important milestone. There is a pressing need to address NASH and this is reflected in the high level of interest in the trial shown by our globally appointed investigators and their keenness to recruit patients. We are continuing to work closely with our appointed sites to support the recruitment of this trial.