Immuron Reports Results in Severe Alcoholic Hepatitis Clinical Trial
August 08 2019 - 12:00PM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the treatment of gut mediated diseases,
today announced the topline results of the clinical study conducted
by the TREAT Consortium which was funded by the National Institute
of Alcohol Abuse and Alcoholism (NIAAA).
The primary objective of the TREAT-003 study was
to evaluate the safety and efficacy of IMM-124E at two oral dosage
levels as compared with a placebo and provide proof of concept in
human subjects for the Mechanism of Action (MoA) in patients with
severe alcoholic hepatitis being treated with steroids. The study
was conducted at three clinical sites in the USA and supported by a
UO1 grant from NIAAA. A total of 57 patients with Severe Alcoholic
Hepatitis (SAH) with a Model for End Stage Liver Disease (MELD)
Score ranging from 21-28 were enrolled into the clinical study and
were treated with either IMM-124E or placebo for 28 days (placebo
N=20, IMM-124E 2400 mg/day N=18, IMM-124E 4800 mg/day N= 19). No
Suspected Unexpected Serious Adverse Reactions (SUSAR) were
reported and no differences in Serious Adverse Events (SAE) were
observed across the three arms of the study and no SAE was
considered related to the study drug by investigators. Both doses
of IMM-124E in the study (2400mg and 4800mg) were well tolerated.
The circulating endotoxin levels were variable but statistically
similar across the study arms at baseline, day 7 and day 30. There
were 9 deaths reported over a six-month period for the entire
cohort and there were no significant differences across study
groups. The MELD score and its components improved in survivors
especially at day 30 onwards but there were no significant
differences across study arms. These data indicate that IMM-124E is
safe to use in patients with severe alcoholic hepatitis but does
not reduce circulating lipopolysaccharide levels, mortality or have
an impact on MELD score in the study population.
"Alcoholic hepatitis occurs in a
setting of altered intestinal permeability and
high endotoxin load,” said Arun Sanyal,
Professor of Gastroenterology and Hepatology from the Virginia
Commonwealth University in Richmond, USA and the study lead
Principle Investigator.
"The IMM-124E drug candidate has been developed
to target LPS in the gut and prevent it translocating into the
portal circulation and the major objective was to determine if
orally administered IMM-124E could reduce endotoxemia in patients
with severe alcoholic hepatitis being treated with steroids. In
this extreme clinical setting in patients with established severe
disease and very high endotoxin load, the study results
demonstrated that during the 28-day treatment period there was no
statistically significant reduction of serum endotoxin levels or
markers of liver injury in the treatment groups when compared to
placebo. The possibility of using IMM-124E prior to development of
severe disease and its ability to reduce endotoxin load in that
setting remains unexplored. This is a disease with a high mortality
rate, nine patients enrolled in the study died due to complications
associated with the disease. There remains an urgent medical need
for new treatments.”
Immuron CEO Dr. Gary Jacob commented:
“Immuron was pleased to support this important
initiative which was funded by the NIAAA to conduct research and
develop potential new treatments for severe alcoholic hepatitis
patients. The Company remains focused on its own clinical
development pipeline and pursuing the registration of Travelan®
with the FDA as the only approved drug to prevent Travelers
Diarrhea, IMM-529 to prevent Clostridium difficle infection
recurrence and expanding our anti-infective preclinical programs
with the US Department of
Defense.”
COMPANY
CONTACT:Gary S. Jacob, Ph.D.Chief
Executive OfficerPh: +61 (0)3 9824 5254info@immuron.com |
AUS INVESTOR
RELATIONS: Peter
TaylorNWR CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
USA INVESTOR RELATIONS:Dave Gentry -
CEO RedChip Companies, Inc. US Ph: +1 (407) 491 4498
dave@redchip.com |
ABOUT IMMURON:Immuron Limited
(ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical
company focused on developing and commercializing orally delivered
targeted polyclonal antibodies for the treatment of inflammatory
mediated and infectious diseases. Immuron has a novel and safe
technology platform with one commercial asset generating revenue.
In Australia, Travelan® is a listed medicine on the Australian
Register of Therapeutic Goods (AUST L 106709) and is indicated to
reduce the risk of Travellers’ Diarrhea, reduce the risk of minor
gastro-intestinal disorders and is antimicrobial. In Canada,
Travelan® is a licenced natural health product (NPN 80046016) and
is indicated to reduce the risk of Travellers’ Diarrhea. In the
U.S., Travelan® is sold as a dietary supplement for digestive tract
protection in accordance with section 403 (r)(6) of the Federal
Drug Administration (FDA). The company now has plans to develop a
U.S. registration dossier for IMM-124E for Travellers’ Diarrhea.
Immuron’s second clinical-stage asset, IMM-529, targets Clostridium
difficile Infections (CDI), and is presently in a clinical trial in
CDI patients. These products together with the Company’s other
preclinical immunotherapy pipeline products currently under
development targeting immune-related and infectious diseases are
anticipated to meet pressing needs in the global immunotherapy
market.
For more information visit:
http://www.immuron.com
About the TREAT003 Study
This study was conducted by the TREAT Consortium
which is funded by the National Institute of Alcohol Abuse and
Alcoholism (NIAAA) to purse translational investigations in
alcoholic hepatitis. The TREAT Consortium is made up of
investigators from Indiana University School of Medicine
(Indianapolis, IN), Mayo Clinic (Rochester, MN) and Virginia
Commonwealth University (Richmond, VA). The IMM-124E study drug and
matching placebo were provided by Immuron Limited. The study is a
Phase II proof of concept multicenter, randomized, double-blind
study comparing 2 doses of IMM-124E to placebo for the treatment of
patients with Severe Alcoholic Hepatitis. The trial enrolled 57
patients at 3 clinical sites in the United States of America
(Indiana University School of Medicine, Indianapolis, IN, Mayo
Clinic, Rochester, MN and Virginia Commonwealth University,
Richmond, VA).
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