Immuron initiates new studies for IMM-124E

Company News

Immuron (ASX:IMC) has initiated several studies designed to develop evidence supporting the unique mechanism of action (MOA) of IMM-124E in non-alcoholic steatohepatitis (NASH).

The studies will be done in partnership with Sanyal Biotechnology and Duke University, under the leadership of Dr Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology at VCU School of Medicine and the founder of SanyalBio, and Dr Anna-Mae Diehl, Professor of Medicine & Director at the Duke Liver Center.

According to the company, the studies aim to further expound on the pre-clinical and clinical evidence previously gathered on IMM-124E for the treatment of NASH. These studies are expected to run throughout CY2017.

IMM-124E is an immunomodulatory therapeutic with broad application across diseases and conditions associated with excess peripheral chronic inflammation. The anti-inflammatory effect of IMM-124E in NASH is supported by the company’s pre-clinical and clinical studies to date, including the outstanding results of the CCl4 liver fibrosis model, demonstrating IMM-124E’s anti-fibrotic effect.

"In Phase 1 clinical studies, IMM- 124 was found to improve liver enzymes, insulin resistance (OGTT and HgbA1c), and dyslipidemia (LDL)," said the company.

Commented Dan Peres, Immuron’s head of medical: “We are excited to collaborate with Dr Sanyal and Dr Diehl whom are both at the pinnacle of NASH research. Both groups are to conduct sophisticated studies using 2 different NASH mice models mimicking the full spectrum of human NASH from simple steatosis to meaningful fibrosis and cirrhosis. Since IMM-124E is a multi-factorial therapeutic that harnesses the immune system within the gut-liver axis to tackle NASH, we believe that such models would demonstrate the full therapeutic effect of IMM- 124E on NASH.”

Studies at Sanyal Biotechnology will use their proprietary Diet Induced Animal Model Of Non-alcoholic fatty liver Disease (DIAMOND). This model was shown to naturally develop Non-Alcoholic Fatty Liver Disease (NAFLD), NASH, Fibrosis, and liver cancer in response to a high fat high sugar diet.

“We look forward to continue working with Immuron to further elucidate how IMM-124E’s strong antiinflammatory properties affect the liver and NASH in particular," said Dr Arun Sanyal, founder of SanyalBio. "SanyalBio will test the effects of IMM- 124E on modulation of NAFLD activity and resolution of steatohepatitis on the DIAMOND mouse model. We anticipate the studies to be completed by mid-year 2017.”

Dr Diehl’s team at Duke University will utilise another mouse model also shown to develop progressive fatty liver disease similar to that of humans.

“My research team is excited to collaborate with Immuron to investigate how their novel treatment for NAFLD influence hepatic immune responses involved in fatty liver injury," said Dr Diehl.

"Our lab has long believed that the gut-liver axis plays an important role in the pathogenesis and progression of NAFLD. Indeed, a series of publications from my group between 2000-2003 provided the first evidence that intestinal microbiome was altered in obese mouse models of NAFLD and demonstrated that these intestinal abnormalities drove altered hepatic immune responses and increased inflammatory signaling in the liver. Since then, a large body of evidence that supports these key concepts has been generated by numerous other investigators the NAFLD field, confirming that the gut-liver axis is a robust therapeutic target in this disease. Our collaboration will provide exciting new information that will further advance knowledge in this area and offers the thrilling prospect of new treatments for patients with NASH.”