Immuron Executes Travelan Clinical Trial Agreement with US-based Pharmaron
October 04 2022 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company that has developed
two commercially available oral immunotherapeutic products for the
treatment of gut mediated diseases, is pleased to announce that it
has executed a Master Service Agreement with US-based Pharmaron
CPC, Inc. a Maryland Corporation located in Baltimore USA.
The Phase II clinical trial will evaluate the
efficacy of a single dose regimen of Travelan® in a controlled
human infection model (CHIM) using the enterotoxigenic Escherichia
coli (ETEC) strain H10407. Previous US military field studies have
shown that for military personnel deployed in austere environments
compliance is low with products dosed more than once per day. The
proposed Travelan dosing regime is potentially more amenable for
use in military populations. The new planned clinical study will
enrol up to 60 volunteers each will be randomly assigned to receive
either a once-daily dose of 1200 mg of Travelan® or placebo. This
study will occur across two cohorts (n=15 Travelan® subjects and
n=15 placebo subjects per cohort), as the inpatient unit can
accommodate up to 30 study participants at a time. The proposed
clinical development program is being funded in part by AU$6.2
(US$4.5) million award (ASX announcement January 12, 2022) from the
US Department of Defense.
Immuron is currently on track to submit the
Investigational New Drug (IND) application to the US Food and Drug
Administration by end of 2022 and will be the sponsor of the
clinical study which is planned to begin in 1H 2023 subject to FDA
approval with headline results from the clinical trial expected in
2H 2023.
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and among US
troops deployed overseas. The morbidity and associated discomfort
stemming from diarrhea decreases daily performance, affects
judgment, decreases morale and declines operational readiness. The
first line of treatment for infectious diarrhea is the prescription
of antibiotics. Unfortunately, in the last decade, several enteric
pathogens have an increasing resistance to commonly prescribed
antibiotics. In addition, travelers' diarrhea is now recognized by
the medical community to result in post-infectious sequelae,
including post-infectious Irritable Bowel Syndrome and several
post-infectious autoimmune diseases. A preventative treatment that
protects against enteric diseases, is a high priority objective for
the US Military.
This release has been authorised by the
directors of Immuron Limited.
COMPANY CONTACT:
Steven LydeamoreChief Executive OfficerPh: +61
(0)3 9824 5254info@immuron.com
About Travelan®
Travelan® is an orally administered passive
immunotherapy that prophylactically reduces the likelihood of
contracting travelers’ diarrhea, a digestive tract disorder that is
commonly caused by pathogenic bacteria and the toxins they produce.
Travelan® is a highly purified tabletized preparation of hyper
immune bovine antibodies and other factors, which when taken with
meals bind to diarrhea-causing bacteria and prevent colonization
and the pathology associated with travelers’ diarrhea. In
Australia, Travelan® is a listed medicine on the Australian
Register for Therapeutic Goods (AUST L 106709) and is indicated to
reduce the risk of Travelers’ Diarrhea, reduce the risk of minor
gastro-intestinal disorders and is antimicrobial. In Canada,
Travelan® is a licensed natural health product (NPN 80046016) and
is indicated to reduce the risk of Travelers’ Diarrhea. In the
U.S., Travelan® is sold as a dietary supplement for digestive tract
protection.
About Travelers’ diarrhea
Travelers’ diarrhea is a gastrointestinal
infection with symptoms that include loose, watery (and
occasionally bloody) stools, abdominal cramping, bloating, and
fever, Enteropathogenic bacteria are responsible for most cases,
with enterotoxigenic Escherichia coli (ETEC) playing a dominant
causative role. Campylobacter spp. are also responsible for a
significant proportion of cases. The more serious infections with
Salmonella spp. the bacillary dysentery organisms belonging to
Shigella spp. and Vibrio spp. (the causative agent of cholera) are
often confused with travelers’ diarrhea as they may be contracted
while travelling and initial symptoms are often
indistinguishable.
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.
For more information visit:
http://www.immuron.com
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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