Phase IIb NASH/Fatty Liver trial cleared without FDA raising concern

Us Fda Clears Investigational New Drug (Ind) Application & Phase 2b Trial for Immuron’s Nash/Fatty Liver Therapeutic

Unmet medical need provides large global opportunity
Immuron’s NASH/Fatty Liver therapeutic derives from the same platform as Travelan®

Melbourne, Australia, 10 January 2012: Australian biopharmaceutical company Immuron Limited (ASX: IMC), manufacturer of Travelan®, today announced that the United States Food and Drug Administration (US FDA) had cleared an Investigational New Drug (IND) submission to commence a Phase 2b clinical trial of its bovine colostrum-derived therapeutic (IMM-124E) for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Fatty Liver.

The trial has been designed as a double-blind, placebo-controlled and dose ranging multi-centre trial with sites in the United States, Australia and Israel. Its principal aims are to determine the safety and efficacy of Immuron’s orally administered IMM-124E in patients with biopsy- confirmed NASH.

As previously announced Dr Arun J Sanyal, Professor of Medicine at Virginia Commonwealth University, has been appointed global principal investigator for the upcoming clinical trial.

Immuron’s Chief Executive Officer Joe Baini said: “This is a major milestone for Immuron with global significance for an unmet and rapidly growing disease. The FDA has cleared Immuron’s IND submission, without raising any concerns.”

“Based on the encouraging results generated to date, IMM-124E could be the first available and approved treatment for NASH patients in the world and the only product candidate to date that addresses the pathogenesis of the disease. From a commercial perspective it represents an extremely lucrative opportunity for Immuron. We are very excited to commence the trial, which is pending financing."

The potential NASH market is estimated to be a multi-billion dollar market and there are no effective treatments.

NASH (non-alcoholic steatohepatitis) is one of the most common liver diseases in the western world. It is associated with obesity, diabetes and hyperlipidaemia. It affects approximately 5% of the lean population, 20% of the obese population and 50% of morbidly obese people. It resembles alcoholic liver disease but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver (hence another of its names ‘Non-alcoholic Fatty Liver Disease’ along with inflammation and damage. NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly.


Contact
Joe Baini – Chief Executive Officer Rudi Michelson
+61 3 8637 1107 Monsoon Communications
+ 61 3 9620 3333
+ 61 411 402 737

About Immuron Limited

Immuron is a biopharmaceutical company focused on oral immunotherapy treatments using dairy-derived antibody products for humans. Immuron is uniquely positioned with a versatile technology platform capable of generating a wide range of products with a high safety profile. This high safety profile makes it possible to complete pre-clinical studies relatively quickly and increases the prospect that the clinical development of Immuron’s products will be expedited. Immuron’s current products and product candidates target infectious diseases of the gastrointestinal tract, chronic diseases such as fatty liver (NASH), and the prevention of influenza. Immuron has one product in the market, Travelan, for preventing travellers’ diarrhoea. Immuron’s main scientific alliances are with Hadassah Medical Center (Israel), the University of Melbourne and Monash University (Australia).

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