Immuron Initiates NASH MOA Studies with SanyalBio and with Duke University

Jan. 19, 2017 10:00 am

MELBOURNE, Australia, Jan. 19, 2017 (GLOBE NEWSWIRE) -- Australian biopharmaceutical Company Immuron Limited (ASX:IMC) is pleased to announce the initiation of several studies designed to add to the growing body of 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 respective 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.  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).

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 leverage 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.  It has been described, and published, that the DIAMOND™ mice first become insulin resistant, obese, and dyslipidemic, similar to the metabolic syndrome in humans.  The mice then continue to demonstrate fatty liver disease progression, parallel to human form, and similar clinically, metabolically and histologically to human disease.

Commented Dr. Arun Sanyal, Founder of SanyalBio:

“We look forward to continue working with Immuron to further elucidate how IMM-124E’s strong anti-inflammatory properties affect the liver and NASH in particular.  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 utilize another mouse model also shown to develop progressive fatty liver disease similar to that of humans.  Dr Diehl is one of the world's leading experts in the field of chronic liver disease immunological research and thus a natural partner to continue IMM-124E’s mechanistic studies.

Commented Dr. Anna-Mae Diehl from Duke University:

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.   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.”

Immuron Ltd (ASX:IMC) is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the treatment of immune mediated diseases.  Immuron has a unique and safe technology platform that enables a shorter development therapeutic cycle. The Company currently markets and sells Travelan® for the prevention of travellers’ diarrhoea, whilst its lead product candidate IMM-124E is in Phase 2 clinical trials for NASH, ASH and Pediatric NASH. These products together with the Company’s other preclinical immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in the market.

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About Anna Mae Diehl, MD

Dr. Anna Mae Diehl, M.D. is a Florence McAlister Professor of Medicine & Director, at the Duke Liver Center.  Her research activities have focused on both clinical and pre-clinical studies of chronic liver diseases including alcohol and non-alcoholic liver steatohepatitis, liver regeneration and the role of cytokines in liver disease.  Dr. Diehl serves on Editorial Boards for a number of journals including Hepatology, Practical Reviews in Gastroenterology, the American Journal of Physiology, and the American Journal of Medicine.  Dr Diehl works as a Director of the Duke Liver Center.  Dr. Diehl serves on numerous Committees for the American Association for the Study of Liver Diseases, the American College of Physicians, the International Associate for the Study of Liver Diseases, the American Federation of Clinical Research, the American Society for Clinical Investigation, and the National Institute for Diabetes, Digestive and Kidney Diseases, as well as others.  Dr. Diehl has authored over 100 publications in the field of liver- and gastroenterology-related diseases.

About Sanyal Biotechnology

Sanyal Biotechnology is a contract research organization focused on accelerating the search for a cure for NASH. The company has proprietary technology, the DIAMOND™ mouse, which is a superior mouse model for the development of liver diseases that accompany the obesity and Type 2 diabetes epidemics. Sanyal Biotechnology's preclinical drug screening services enable pharmaceutical companies to identify the compounds which are most likely to succeed in human clinical trials, thus shortening the timeline to drug approval.

Sanyal Biotechnology LLC is a privately held company based in Richmond, Virginia. The company was spun out of Virginia Commonwealth University in 2015.

Company Contact:			
Thomas Liquard
Chief Executive Officer
Ph: +61 (0)3 9824 5254

Immuron Media Relations:
John Beveridge
Monsoon Communications
Ph: +61 (0)3 9620 3333

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January 19, 2017 - 10:00 AM EST

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