Full Press Release Details
Travelers' Diarrhea Market Update
Australia, October 12, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing
and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to provide
shareholders and the market with an update on the planned clinical programs in Travelers' Diarrhea (TD).
Board of Immuron has approved company plans to recommence the CMC related activities regarding its investigational drug IMM-124E
required to support an investigational new drug (IND) application to the FDA and the proposed phase III clinical study in TD.
company has recently been advised by the Uniformed Services University (USU) that it has recommenced the planned clinical trial
program to evaluate the efficacy of non-antibiotic OTC products in Travelers' Diarrhea and will provide a purchase order
for IMM-124E. USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City
Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical products for
TD and inform strategies for Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter
clinical trial designed to evaluate the effectiveness of 3 commercially available nutraceuticals: A prebiotic (Bimuno ),
a probiotic (Florastor ) and IMM-124E (Travelan ) passive immunoprophylaxis verses a placebo, for
prophylaxis during deployment or travel to a high-TD risk region. All study participants (1336 in total) will be randomized to
one of the three active products or placebo (334 per arm).
company is also pleased to announce that it has executed a consultancy agreement with Professor Teena Chopra, Professor of Medicine
Wayne State University School of Medicine, Detroit Michigan. Professor Chopra is an Infectious Disease Epidemiologist with a specific
interest in Clostridiodes difficle (C.difficle) infections. Professor Chopra and her team recently published their research
findings on patients at a hospital associated with the Detroit Medical Center presenting with both SARS-CoV-2 and C.difficle1.
Both infections can manifest as digestive symptoms and merit screening when assessing patients with diarrhea. The hospitals
associated with the Detroit Medical Centre treated over 600 patients presenting with COVID-19 during the peak of the pandemic.
Professor Chopra and her team noted most predominantly included pulmonary symptoms but a small subset of less than 10% of the
cases also included gastrointestinal events. Professor Chopra is building a registry of the patients presenting with gastrointestinal
events to better understand this cohort and the unique medical challenges they present and will be an invaluable resource to access.
difficile infection (CDI) is a challenging disease, with a recurrence rate of 15%-20% and a mortality rate of 5%. When
CDI is present as a co-infection with COVID-19, CDI therapy can be difficult to monitor if diarrhea persists because of COVID-19.
Our most recent research findings highlight the importance of judicious use of antibiotics for potential secondary bacterial infection
in patients with COVID-19. Antibiotics are known to have unintended consequences, such as C. difficile infection. We recently
identified 9 patients in our study who were elderly, an age group at higher risk for complications from overuse of antibiotics,
such as adverse events, antibiotic resistance, and concomitant infections like CDI. Immuron's technology platform is intriguing
because it potentially offers a non-antibiotic solution to this debilitating disease" said Professor Chopra.
release has been authorised by the directors of Immuron Limited.
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).
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.
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.
more information visit: http://www.immuron.com
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