Full Press Release Details
Awarded $6.2 Million to Clinically Evaluate a Military Strength Dosing Regimen for Travelan
Australia, January 12, 2022: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing
and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, is pleased to announce the funding
of a new research agreement with the U.S Department of Defense.
focus of this new agreement, entitled "Biologics License Application (BLA) of a therapeutic Bovine Immunoglobulin supplement targeting
Travelers' Diarrhea caused by Enterotoxigenic Escherichia Coli (ETEC)", is aimed at testing and confirming the efficacy of
a single larger dose regimen of Travelan in a controlled human infection model (CHIM) clinical study using the enterotoxigenic Escherichia
coli (ETEC) strain H10407. This single larger dosing regime is potentially more amenable for use in military populations. Up to 60
volunteers will be enrolled in the clinical study and 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. Results of the proposed clinical study will also inform on dosing in the
pivotal Phase 3 registration trials for BLA licensure. A project kickoff meeting for this award has been scheduled for the end of January
with the U.S Government sponsors.
proposed development program is based on the past commercial and clinical trial experience with Travelan . Two company sponsored
clinical studies have demonstrated that Travelan conferred 84% to over 90% protective efficacy against moderate to severe diarrhea
upon challenge with ETEC in comparison to a placebo. These clinical studies were performed using two different doses of Travelan
(200 mg and 400 mg), administered 3 times a day. Ongoing discussions with Army and Navy leadership have highlighted that such a regimen
is cumbersome for military personnel deployed in austere environments and military field studies have shown that compliance is low with
products dosed more than once per day.
new project expands our clinical development program and represents the first of several significant clinical trials which the company
expects to undertake with the US Military in 2022. The NMRC plans to clinically evaluate the protective efficacy of our new oral therapeutic
targeting Campylobacter and ETEC this year in two controlled human infection-model clinical trials, with one trial focusing on the ability
of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis, and the second trial focusing on ETEC
infections" said Dr. Jerry Kanellos, CEO of Immuron. "The new funding is testament to the value proposition our hyperimmune
bovine polyclonal colostrum technology offers to benefit the U.S. Military as well as the civilian international travelling population."
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.
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 infectious diseases.
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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