Full Press Release Details
Immuron Opens Clinical Site to Evaluate
of IMM-529 for Treatment of Clostridium
Difficile Infection (CDI)
Melbourne, Australia, August 28th,
2017: Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian microbiome biopharmaceutical company focused on developing and
commercializing oral immunotherapeutics for the treatment of many gut mediated diseases, today announced the successful site initiation
of its first-in-human, IMM-529 clinical study for the treatment of Clostridium Difficile Infection (CDI).
Immuron is pursuing the biopharmaceutical
research and development of an effective and safe treatment of CDI which according to the Centre for Disease Control and Prevention
(CDC), infects more than 450,000 patients causing over 29,000 deaths, per year in the United States alone. The IMM-529 drug product
has been shown in pre-clinical tests to be an effective treatment. Success in this trial will provide a firm foundation to the
Board and Management that the Company's IMM-529 drug product has significant potential for continued clinical development.
announcement to the market on August 9th, 2017 advising receipt of approval from the Israeli Ministry of Health's (MoH)
and the Hadassah Medical Center Ethics Committee to perform the clinical study, Immuron has now implemented the opening of the
site to enroll the first of 60 patients by mid-September 2017.
randomised, double-blind, placebo-control clinical study is designed to evaluate the safety and preliminary efficacy of Immuron's
IMM-529 drug product for the treatment of CDI.
will be randomized and in addition to their standard of care treatment will receive either IMM-529 or placebo three times daily
for a total of 28 days which will then be followed by two months of monitoring for any recurrence of disease. The primary objective
of the study is to assess patient safety and tolerability of IMM-529, while secondary endpoints will evaluate the preliminary efficacy
of the product evaluated by determining duration and severity of symptoms, and the rate of recurrence. Topline results are anticipated
in the fourth quarter of 2018.
The study will be conducted under the leadership
of Professor Yoseph Caraco, who is the head of the Clinical Pharmacology Unit at Hadassah Medical Center in Jerusalem, which specializes
in early stage clinical studies.
The protocol for the study was jointly
developed by Immuron with Professor Caraco and Professor Allon Moses, Chairman of the Department of Clinical Microbiology and Infectious
Diseases, and Professor Jacob Strahilevitz of the Department of Clinical Microbiology and Infectious Diseases at Hadassah.
IMM-529 compound is a unique combination of polyclonal antibodies, targeting all main virulence factors of CDI," said Dr.
Dan Peres, Chief Medical Officer at Immuron. "We anticipate IMM-529 will exhibit the same level of safety as previously demonstrated
with our other compounds, while its "one-of-a-kind" mechanism of action should relieve the diseased gut of the infectious
and toxic burden to allow the microbiome to recuperate and reinstate homeostasis."
a true void in the market for an effective treatment of CDI, and we are confident this compound presents a solution for the many
patients diagnosed with CDI each year."
IMM-529 is an oral compound taken three
times per day consisting of a combination of polyclonal antibodies targeting the Clostridium-Difficile's toxin B responsible
for the clinical manifestation of the disease, as well as the spores and the vegetative cells which are thought to be the primary
cause of the recurrences. The delivery of IMM-529 results in localized toxin B neutralization, while binding to the C-Diff spores
and vegetative cells to prevent further colonization. IMM-529 antibodies have been shown to survive transit through the stomach
and remain functional up through the large intestine.
In addition, the antibodies in IMM-529 have
demonstrated to cross-react with a variety of human and animal C. difficile isolates and their associated toxin B vegetative
cell and spore components. The antibodies in IMM-529 have also been shown to neutralize Toxin B from a historical C. difficile
strain (630), and from a hypervirulent (HV) strain which caused the worldwide outbreaks in 2011.
In preclinical studies, IMM-529 demonstrated
superiority in prophylactic use, treatment of disease, and the prevention of recurrence. All results were published in the Nature
Journal Scientific Reports earlier this year (Hutton et al Scientific Reports 2017;7:3665).
difficile is the causative organism of antibiotic-associated colitis. Colonization is facilitated by disruption of normal
intestinal flora due to antimicrobial therapy. The organism is capable of elaborating exotoxins that bind to receptors on intestinal
epithelial cells, leading to inflammation and diarrhea and, in severe cases, death. Clostridium difficile Infection
(CDI) has become a major-medical concern causing an estimated annual economic burden of more than US$10 billion globally. The problem
is especially acute in hospitals and in long-term in-patient care facilities. Over 453,000 cases of recurrence are recorded annually
while an estimated 29,300 patients die each year from CDI infections in the USA alone (*
CIDRAP Center for Infectious Disease Research and Policy (Feb 2015)).
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.