Immuron Highlights Recent Milestones in Quest to Effectively Treat Multiple Forms of Fatty Liver Diseases That Impact Millions

Company’s lead drug candidate IMM-124E is well-positioned to pioneer successful treatment for NASH and NAFLD, diseases for which there is no proven effective treatment

Company provides overview of existing clinical trials for IMM-124E that upon execution and analysis, will establish the drug candidate as a leader in the global ‘Dash to NASH’ and other fatty liver disease treatment markets

Company to conduct US west coast investor roadshow following presentation at Rodman & Renshaw 19th Annual Global Investment Conference

MELBOURNE, Australia, Sept. 19, 2017 (GLOBE NEWSWIRE) -- Immuron Limited (ASX:IMC)(NASDAQ:IMRN), an Australian microbiome biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the treatment of many gut mediated diseases, today highlighted a number of recent milestones surrounding its clinical development of IMM-124E, a drug candidate designed to treat multiple forms of fatty liver disease, including nonalcoholic steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD).

Approximately 16 million, or 5%, of the US population currently suffer from NASH, while 75-100 million Americans are afflicted with NAFLD. This creates a tremendous market opportunity for the handful of biopharmaceutical companies aggressively pursuing effective treatments for these diseases which target the liver. One such company, Intercept Pharmaceutical, recently received attention from the media and capital markets after issuing a letter that warned physicians against overdosing patients on its liver-disease drug, Ocaliva.

Fatty liver diseases are frequently caused by high weight and obesity, genetics, and diet that result in inflammation of the liver. Immuron uses an innovative approach to addressing this condition, one that focuses on treating bacteria of the gut using a specific set of antibodies. Ultimately, IMM-124E is designed to block and reduce bacteria growth without negatively impacting essential microbiota. This process has thus far produced a strong safety profile for IMM-124, whose recent interim analysis indicated no safety concerns or adverse events.

Immuron is currently in the process of executing three clinical trials for its drug candidate, IMM-124E, that it believes represents a solution for the millions of patients suffering from NASH:

• Recently in a Phase II clinical trial involving multicenter sites in Australia, Israel and the United States of America, Immuron achieved its recruitment goal of at least 120 patients this year by successfully enrolling 133 patients with biopsy proven NASH. This study – led by Dr. Arun Sanyal, the former President of AASLD (American Association for the Study of Liver Diseases) and current Chair of the Liver Study Section at the National Institute of Health (NIH) – is expected to yield top-line results in the fourth quarter (Q4) of 2017.
   
• Dr. Arun Sanyal is also the lead Principle Investigator of the Immuron alcoholic steatohepatitis (ASH) clinical study at Duke University, also funded by the NIH. Thus far, over 50% of the targeted 66 patients have been randomized into the study, whose top-line results are expected in Q1 2019.
   
• Immuron is currently undergoing a NIH-funded Phase II double blind, placebo control, randomized clinical study of IMM-124E at Emory University, led by Dr. Miriam Vos, who specializes in the treatment of gastrointestinal disease in children as well as fatty liver disease and obesity. The study enrolled its first patient in February 2017, and has so far randomized over 20% of the targeted 40 patients into the study. The top-line results for this study are expected in the Q4 2017.
   
• In July 2017, Immuron reported data from an interim analysis to evaluate safety of IMM-124E. The report confirmed that there were no safety concerns or adverse events, and reported efficacy signals on liver enzymes (ALT and AST) that demonstrated a dose-related reduction in both treatment doses at 24 weeks, though not statistically different than placebo. As these parameters inherently fluctuate over time and are significantly affected by baseline values the interim analysis committee also had scheduled to perform additional analyses on the data set to correct for these inherent variations. Comparing the Area Under Curve for the ALT/AST data over time of IMM-124E to Placebo, accounts for all the available data. Such analysis demonstrated a significant reduction of ALT and AST over time (AUC ANCOVA analysis) compared to placebo. A dose-related effect was reported when the greatest decrease occurred in the highest dose group, with the low dose group decreasing by an intermediate amount compared with the placebo group. The Company believes that this documented effect, together with a correlation between ALT and AST, indicate the treatment has the potential to safely reduce liver injury.

Immuron believes that its current strategy of executing three separate clinical trials at the same time for three different, but very related diseases, will ultimately put the Company on a quicker route to commercialization. The proprietary IMM-124 compound has clearly demonstrated its potential to be effective in the treatment of these fatty liver diseases, positioning the Company to fill a true void in the medical community and pharmaceutical industry.

“We are very pleased with the position of our Company and its proprietary technologies within the high growth market for treatments of NASH, NAFLD, and Pediatric NAFLD,” said Dr. Jerry Kanellos, CEO at Immuron. “The narrative for IMM-124E is quite simple – fatty liver disease has long represented challenges for millions of patients and the physicians that treat them. Thus, the market opportunity for a successful, health agency-approved treatment represents potential not only for individuals and the medical community, but also pharmaceutical companies targeting this challenging disease.”

Immuron CEO Dr. Jerry Kanellos recently presented at the Rodman & Renshaw 19th Annual Global Investment Conference in New York City on September 10 – 12. During the presentation, Dr. Kanellos shared updates regarding the Company’s drug candidate pipeline and its various clinical trials, and outlined the market opportunity should the treatments continue to advance towards commercialization. Dr. Kanellos will continue to meet with investors on the US west coast this week.

About Immuron’s IMM-124E:
IMM-124E is a naturally-produced polyclonal antibody biological product intended to prevent and treat liver inflammation and fibrosis from nonalcoholic steatohepatitis (NASH). The dual mechanism of action promotes regulatory T cells which suppress inflammation at the site of disease without inducing generalized immune suppression and without negatively impacting the rest of the gut microbiome. The safety profile also allows for a broad combination with other treatments and supports long-term, chronic use for treatment of mild and moderate patients through oral administration of the anti-LPS antibodies.

ABOUT IMMURON:
Immuron Ltd (ASX:IMC) is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the treatment of many gut 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’ diarrhea whilst its lead product candidate IMM-124E is in Phase 2 clinical trials for NASH and ASH.  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.  For more information visit: http://www.immuron.com

FORWARD-LOOKING STATEMENTS:
Certain statements made in this release are forward-looking statements and are based on Immuron’s current  expectations,  estimates and  projections.  Words such  as  “anticipates,”  “expects,”  “intends,”  “plans,”  “believes,”   “seeks,”   “estimates,”   “guidance”   and   similar expressions  are intended to identify forward-looking statements. Although Immuron believes the forward-looking statements are based on   reasonable  assumptions,   they   are   subject   to   certain   risks   and   uncertainties,   some  of  which  are  beyond  Immuron’s  control, including  those  risks  or  uncertainties  inherent  in  the  process  of  both  developing  and  commercialising technology. As a result, actual results could materially differ   from   those   expressed   or   forecasted   in   the   forward-looking   statements. The forward-looking statements made in this release relate only to events as  of  the  date  on  which  the  statements  are  made.  Immuron will not undertake  any obligation  to  release  publicly  any  revisions   or   updates   to   these   forward-looking   statements   to   reflect   events,   circumstances   or unanticipated  events  occurring  after  the date of this release except as required by law or by any appropriate regulatory authority.