Immuron submits IND for liver disease drug
Tuesday, 08 November, 2011
Melbourne-based Immuron (ASX:IMC) has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its proprietary IMM-124E drug for the treatment of fatty liver disease, including Nonalcoholic steatohepatitis (NASH).
The company also intends to initiate a phase IIb clinical trial to further test the safety and efficacy of the drug. The trial has been designed by Immuron in conjunction with Principal Investigator Professor Arun Sanyal, who is the immediate past President of the American Association for the Study of Liver Diseases (AASLD).
The trial will be a dose ranging placebo controlled, double blind multi-centre study in NASH patients receiving 6 months of active treatment involving sites in Australia, the US and Israel.
IMM-124E is aimed at a market with no existing approved competitors, and is worth an estimated US$4.4 billion ($4.2 billion) per annum in the U.S. alone.
Immuron (ASX:IMC) shares were steady at 5c as of 11am this morning.
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