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In The Spotlight: Immuron Ltd.


The American Depositary Shares of Immuron Limited (IMRN) have gained nearly 33% in the last 5 trading days.

Immuron, an Australian biopharmaceutical company, is focused on developing oral drugs for various immune mediated and inflammatory disorders like non-alcoholic steatohepatitis (NASH) diabetes, colitis, arthritis, inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), liver fibrosis and other chronic disorders.

The Company has two investigational drugs in clinical testing - IMM-124E and IMM-529.

IMM-124E is under phase II trials in the indications of nonalcoholic steatohepatitis (NASH), alcoholic steatohepatitis (ASH), and pediatric nonalcoholic fatty liver disease (NAFLD).

Before, we go into the details, here's an overview of NASH.

NASH refers to liver inflammation due to fat buildup in the liver. Also called a "silent" liver disease since the symptoms are not manifested in early stages, in some patients, NASH can also progress to cirrhosis and liver failure over the years. NASH, is a more severe form of nonalcoholic fatty liver disease, or NAFLD.

There is still no approved drug for treating NASH. Liver transplantation is the only option for NASH cirrhosis at this time. By 2020, NASH is projected to overtake hepatitis C as the leading cause of liver transplants in the U.S.

Immuron's phase II trial of IMM-124E in NASH is fully enrolled with 133 patients with biopsy proven NASH. The primary endpoint is the improvement of liver steatosis as assessed by MRI at the 24 weeks' time point. The key secondary endpoints are change in liver enzyme ALT and metabolic markers.

The top line results from the NASH study are expected this quarter (Q1, 2018).

The phase II trial of IMM-124E in ASH is expected to enroll 66 patients. This study, funded by the US National Institute of Health, has already randomized and dosed 24 patients (Data as of November 2017).

The top line results from the ASH study are expected in 2019.

The phase II trial of IMM-124E in pediatric NAFLD is expected to enroll children aged 6-19 years with nonalcoholic fatty liver disease. This study is also funded by the US National Institute of Health, and top line results are expected in the fourth quarter of 2018.

The second drug candidate IMM-529 is under a phase I/II trial in patients with Clostridium difficile infections (CDI).

Initiated in September 2017, the phase I/II trial of IMM-529 is designed to enroll 60 participants. The study is expected to be completed by May 2018.

Immuron has one marketed product, Travelan, a novel, over the counter ("OTC") product for the prevention of Travellers' Diarrhea. This product brings in annual revenue of over AU$1 million.

Given the fact that Immuron has a couple of catalysts to watch out for in the near term, it is worth keeping an eye on this stock.

Immuron trades on the NASDAQ, Australian Stock exchange and Frankfurt Stock Exchange.
The Company listed its American Depository Shares on the NASDAQ on June 9, 2017, at a price of $10.00 each.

IMRN closed Thursday's trading at $7.03, up 27.12%. It has thus far hit a low of $4.47 and a high of $10.00 on the NASDAQ.

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