Immuron Highlights Recent Milestones in Quest to Effectively Treat Multiple Forms of Fatty Liver Diseases That Impact Million...
19 September 2017 - 10:00PM
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
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.
COMPANY
CONTACT:Jerry KanellosChief Executive
OfficerPh: +61 (0)3 9824 5254jerrykanellos@immuron.com |
|
AUS INVESTOR
RELATIONS:Peter TaylorNWR
CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
|
USA MEDIA
CONTACT:Kate Caruso-SharpeFischTank
Marketing and PR+ 1 646 699 1414kate@fischtankpr.com |
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.
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