Immuron Limited (ASX:IMC) (NASDAQ:IMRN), an Australian microbiome
biopharmaceutical company focused on developing and commercializing
orally delivered targeted polyclonal antibodies for the treatment
of inflammatory mediated and infectious diseases, is today pleased
to announce the successful completion of its colitis preclinical
program at the University of Zürich, Switzerland.
Immuron is pleased to report that oral
administration of IMM-124E was successfully able to treat mice with
immunologically induced colitis. The University of Zürich research
revealed that IMM-124E offered a significant therapeutic benefit on
clinically meaningful study parameters.
In contrast to the results reported in April
2017 using an acute colitis model the latest results were generated
in the T cell transfer model which utilizes immunodeficient mice
which are deficient in functional B and T lymphocytes. In this
model chronic colitis is induced immunologically not chemically.
IMM-124E was administered orally after the onset of colitis
symptoms such as weight loss and macroscopically inflamed colon
were confirmed by colonoscopy prior to the initiation of
treatment.
The results reported clearly demonstrated that
oral treatment with IMM-124E resulted in significant alleviation of
colitis symptoms, including;
- Reduced weight loss
- Reduced disease activity scores
- Reduced shortening of the colon
- Reduced levels of macroscopically detectable
colitis
- Histology of the terminal and proximal colon also
confirmed reduced colitis in the drug treatment arms.
The research work has been submitted for
presentation at the annual United European Gastroenterology Week
conference which will be held on the 20th to 24th of October 2018
in Vienna, Austria.
"This study concludes our comprehensive
preclinical program to evaluate the therapeutic potential of
IMM-124E in our established colitis animal models." said
Gerhard Rogler, Professor of Gastroenterology and Hepatology from
the University of Zürich, Switzerland and the study lead Principle
Investigator.
"Our results clearly demonstrate that treatment
with IMM-124E significantly reduces intestinal inflammation via
reducing the accumulation and differentiation of pathogenic T
cells, while concomitantly enhancing the induction of regulatory
cells. This indicates that IMM-124E inhibits lipopolysaccharide
(LPS)-mediated effects on the mucosal immune system, resulting in
reduced intestinal inflammation. Summarized, our findings indicate
that IMM-124E administration represents a novel therapeutic
strategy to induce or maintain remission in IBD patients”.
Immuron Interim CEO Dr. Jerry Kanellos
commented:
“The IMM-124E drug candidate has been developed
to target the endotoxin, LPS in the gut and prevent it
translocating into the portal circulation. This first in class
mechanism of action was recently confirmed in our
Non-Alcoholic Steatohepatitis (NASH) clinical
study, where IMM-124E demonstrated a statistically significant
reduction in serum LPS levels, when compared to placebo in patients
with biopsy confirmed NASH.
The University of Zürich research program adds
to our published preclinical and clinical data which has repeatedly
shown that IMM-124E delivers a significant reduction in liver and
mucosal inflammation. LPS endotoxins have been widely implicated as
a major driver of inflammation in Colitis, Inflammatory bowel
disease (IBD), NASH as well as numerous Auto-Immune
Diseases”.
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COMPANY CONTACT: Jerry
KanellosChief Executive Officer (Interim)Ph: +61 (0)3 9824
5254jerrykanellos@immuron.com |
USA INVESTOR RELATIONS: Jon
CunninghamRedChip Companies, Inc.US Ph: +1 (407) 644 4256,
(ext. 107)jon@redchip.com |
AUS INVESTOR RELATIONS: Peter
TaylorNWR CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
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ABOUT IMMURON:
Immuron Limited (ASX:IMC) (NASDAQ:IMRN), is an
Australian microbiome biopharmaceutical company focused on
developing and commercializing orally delivered targeted polyclonal
antibodies for the treatment of inflammatory mediated and
infectious 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
Travelers’ Diarrhea and its lead clinical candidate, IMM-124E, is
in Phase II clinical trials for Non-Alcoholic
Steatohepatitis (NASH), Severe Alcoholic
Hepatitis (SAH) and Pediatric Non-Alcoholic Fatty
Liver Disease (NAFLD). Immuron’s second clinical
stage asset, IMM-529, is targeting Clostridium difficile
Infections (CDI). 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 global immunotherapy market.
For more information visit:
http://www.immuron.com
About the IMM-124E Study
The IMM-124E study is a Phase II proof of
concept multinational, randomized, double-blind study comparing 2
doses of IMM-124E to placebo for the treatment of NASH in adults
with any stage biopsy-proven NASH. The trial enrolled 133 patients
across 25 clinical sites in Australia (6), Israel (2) and the USA
(17). The trial has 12 scheduled visits over a 28-week study
duration, with 24 weeks of treatment and four weeks of follow-up
and screened a total of 237 patients. It initially aimed to enroll
120 patients with biopsy-proven NASH, and was fully enrolled at 133
patients, which exceeds the original 120-patient target. The
patients were randomized into three arms: placebo, high dose
(1200mg), and low dose (600mg). The established primary endpoints
of the study were improvement of liver steatosis, as assessed by
magnetic resonance imaging (MRI) comparing the mean values. The key
secondary endpoints are: change in ALT as well as other liver
enzymes and metabolic markers. IMM-124E enrolled adults with
all-stage biopsy proven NASH up to 12 months of randomization under
an IND approved by the FDA.
About IMM-124E
IMM-124E is an oral, three-times-daily,
non-absorbable compound containing poly-clonal anti-LPS
immunoglobulins proposed to interact with the gut LPS and immune
system to achieve an immunomodulatory effect reducing LPS-related
inflammation and inducing tolerance. Because of this unique
mechanism of action, targeting multiple pathways, IMM-124E has the
potential to play a differentiated role in the management of NASH
and may form the cornerstone of NASH combination treatment
strategies, both as a single agent and in combination with other
agents.
In addition to the adult NASH study, IMM-124E is
also being evaluated in two NIH funded Phase II proof-of-concept
studies of IMM-124E in children with Pediatric NAFLD and adults
with Severe Alcoholic Hepatitis.
About Non-Alcoholic Steatohepatitis (NASH)
Nonalcoholic fatty liver disease (NAFLD) is
characterized by a buildup of fat in the liver that is not
attributable to excessive alcohol use, NASH is a severe type of
NAFLD, which is characterized by the accumulation of fat in the
liver with no other apparent causes. NASH occurs when the
accumulation of liver fat is accompanied by inflammation and
cellular damage. The inflammation can lead to fibrosis (scarring)
of the liver and eventually progress to cirrhosis, portal
hypertension, liver cancer, and eventual liver failure, requiring
the patient to have a liver transplant.
NAFLD is one of the most common causes of liver
disease in the U.S., with the majority of patients having simple
fatty liver. It is estimated that between 30-40% of adults in the
U.S. have NAFLD. Although the epidemiology of NAFLD is not fully
understood, the condition is associated with certain conditions,
including obesity and obesity related conditions (e.g., type 2
diabetes). Researchers have found NAFLD in 40-80% of people with
type 2 diabetes and in 30-90% of people who are obese. Over 90% of
severely obese people undergoing bariatric surgery had NAFLD in
epidemiological studies. NAFLD is not age-specific and has been
shown to affect 10% of children ages 2-19, although the risk of
developing NAFLD increases with age.
NASH is an emerging health crisis impacting 3%
to 5% of the U.S. population and 2% to 4% globally, and is the
fastest growing cause of liver cancer and liver transplant in the
U.S. The increasing prevalence of NASH is attributed to the growing
obesity epidemic and the disease is often diagnosed in patients who
have diabetes, high cholesterol or high triglycerides. There is
currently no approved treatment for NASH. NASH is projected to
reach over $25B annually by 2026 with a compound annual growth rate
(CAGR) averaging 45% in the 2018-2026 period. Research analysts
believe that peak sales for IMM-124E could exceed $1.8B in the U.S.
alone.
About Lipopolysaccharide
(LPS)
Lipopolysaccharide (LPS) also known as bacterial
endotoxin is the major component of the outer membrane of
Gram-negative bacteria which are natural inhabitants of the
mammalian intestinal tract. These enteric bacteria serve as the
source for systemic endotoxin exposure. There is a continuous
release of endotoxin (LPS) in the host intestine with no
consequence to the individual and if a small amount of endotoxin
leaks into the portal vein, it is cleared by the liver, therefore,
never entering the circulatory system. However, conditions that
interfere with the integrity of the protective intestinal mucosal
epithelium, such as our high fat, high sugar, western diets,
chronic alcohol consumption or ischemia, increased LPS absorption
into the hepatic portal system occurs. If the resulting endotoxemia
overwhelms the liver’s capability to metabolize absorbed LPS, an
intense hepatic inflammatory response ensues. When bacterial cells
are lysed by the immune system, bacterial fragments containing LPS
are released into the circulation, causing fever, diarrhea, and
possible fatal endotoxic shock (also called septic shock).
Physiological response to inflammatory mediators can lead to
hepatic damage. Elevated serum LPS is associated with increased
risk for developing, Alcoholic Hepatitis, Alzheimer’s disease,
Auto-immune diseases, Cancer, Diabetes, Heart Disease, Inflammatory
Bowel Disease (Crohn’s Disease, Ulcerative Colitis), Metabolic
Syndrome, Non-Alcoholic Fatty Liver Disease and many others.
FORWARD-LOOKING STATEMENTS:
This press release may contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934,
each as amended. Such statements include, but are not limited
to, any statements relating to our growth strategy and product
development programs and any other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock value. Factors that could
cause actual results to differ materially from those currently
anticipated include: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; risks relating to
the timing of starting and completing clinical trials;
uncertainties relating to preclinical and clinical testing; our
dependence on third-party suppliers; our ability to attract,
integrate and retain key personnel; the early stage of products
under development; our need for substantial additional funds;
government regulation; patent and intellectual property matters;
competition; as well as other risks described in our SEC filings.
We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
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