Full Press Release Details
to host Live Virtual Event
Australia, April 15, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company
is pleased to advise our Chief Executive Officer, Steven Lydeamore together with our Chief Scientific Officer, Dr. Jerry Kanellos and
Research & Development Manager, Dr. Joanne Casey will be hosting a Live Virtual Event on Tuesday, April 30 at 10am AEST / Monday,
April 29 at 8pm EST.
BOUND FOR PHASE 3 CLINICAL TRIALS
Immuron's Positive Phase 2 Travelan Results and Upcoming Phase 3 Trial
like to invite shareholders and potential investors to Immuron Ltd's (ASX:IMC) / (NASDAQ:IMRN) upcoming Virtual Symposium!
Steve Lydeamore, CEO Immuron, Dr. Joanne Casey, R&D Manager Immuron, and Dr. Jerry Kanellos, COO Immuron, as they explore the Company's
positive Phase 2 Travelan (IMM-124E) results, upcoming Phase 3 trial, proprietary technology behind Immuron's success, and
month, Immuron, a globally integrated biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for
the treatment of gut mediated diseases, reported positive interim topline results from its Phase 2 trial of Travelan. The study's findings
indicated protective efficacy against enterotoxigenic Escherichia coli (ETEC)-induced diarrhea, a common and debilitating condition affecting
travelers, and adds additional data to the established excellent safety and tolerability profile of Travelan. Remarkably, there was a
83.3% reduction in the number of participants requiring early antibiotic treatment compared to placebo and 100% of participants requiring
IV fluids were in the placebo group.
proprietary technology platform combines the natural human nutrition & health benefits of bovine colostrum with a novel class of
specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal tract and can be used to target viruses
or bacteria and neutralize the toxins they produce at mucosal surfaces.
the clinical study, predominantly funded by a US$3.43 million grant from the US Department of Defense, Travelan demonstrated a 36.4%
reduction in cases of moderate to severe diarrhea and a remarkable 66.7% efficacy against severe diarrhea instances, compared to placebo.
This Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study.
30% to 70% of travelers experiencing traveler's diarrhea, according to the CDC, the traveler's diarrhea treatment market
is large and growing at a CAGR of ~7%. According to a Lumanity Opportunity Assessment for IMM-124E, based on the estimated market size
and pricing, the base case yearly revenue in USA for IMM-124E is projected at US$102M.
will now proceed to hold an end of Phase 2 meeting with the FDA to discuss the pivotal Phase 3 registration strategy as well as explore
funding for Phase 3. By merely entering Phase 3, Immuron will be among an exclusive list of ASX biotech stocks in Phase 3.
this webinar, you can expect an insightful exploration into the results, upcoming milestones to come from Immuron, and other research
and development pathways the Company is pursuing as it works to realize the full potential of its proprietary technology platform.
hope to see you on Tuesday, April 30 at 10am AEST / April 29 at 8pm ET.
release has been authorised by the directors of Immuron Limited.
Chief Executive Officer
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.
is generally defined as the passage of 3 unformed stools per 24 hours plus at least one additional symptom (such as nausea, vomiting,
abdominal cramps, fever, blood/mucus in the stools, or fecal urgency) that develop while abroad or within 10 days of returning from any
resource-limited destinations (Leung et al., 2006). Diarrhea continues to be the most frequent health problem among travelers to destinations
in lower- and middle-income regions (Steffen, 2017). Deployed US military personnel, essentially representing a long-term traveller population,
are particularly affected given their population dynamics and the context in which they seek care and treatment (Connor et al., 2012).
Diarrhea is the leading infectious disease threat to the overall health and preparedness of deployed US armed forces, with diarrheagenic
E. coli, Campylobacter spp., and Shigella spp. among the most commonly reported etiologies (Riddle et al., 2006).
proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum. Immuron has
the capability of producing highly specific immunoglobulins to any enteric pathogen and our products are orally active. Bovine IgG can
withstand the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes found in the Gastrointestinal
(GI) tract. Bovine IgG also possesses this unique ability to remain active in the human GI tract delivering its full benefits directly
to the bacteria found there. The underlying nature of Immuron's platform technology enables the development of medicines across
a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal
tract and neutralize the toxins they produce.
was developed using Immuron's platform technology. IMM-124E is produced from the colostrum of birthing cattle that have been immunised
during pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total of 13 ETEC strains are used in
the vaccine to produce high levels of antibodies against selected surface antigens from the most common strains of ETEC.
resultant hyperimmune colostrum IMM-124E from ETEC vaccinated cows contains significant levels of polyclonal antibodies specific for
ETEC antigens LPS, CFA-I and Flagellin (Sears et al., 2017).
antibodies produced in IMM-124E have been found to have a stronger binding and neutralizing activity (than the antibodies of unvaccinated
cattle) against a wide range of LPS antigens including both the variable O-polysaccharide region and the preserved oligosaccharide core
R' region of LPS from the 13 serotypes used in the ETEC vaccine.
is manufactured into a tablet form referred to as Travelan .
P, Porter CK, Swierczewski B and Riddle MS. Diarrhea during military deployment: current concepts and future directions. Curr Opin Infect
Dis. 25(5): 546-54; 2012.
AK, Robson WL, Davies HD. Travelers' diarrhea. Adv Ther. Jul-Aug; 23(4): 519-27; 2006
W, Najnigier B, Stelmasiak T and Robins-Browne RM. Randomized control trials using a tablet formulation of hyperimmune bovine colostrum
to prevent diarrhea caused by enterotoxigenic Escherichia coli in volunteers Scandinavian Journal of Gastroenterology 46: 862-
MS, Sanders JW, Putnam SD, and Tribble DR. Incidence, etiology, and impact of diarrhea among long-term travelers' (US military
and similar populations): A systematic review. American Journal of Tropical Medicine and Hygiene. 74(5): 891-900; 2006.
KT, Tennant SM, Reymann MK, Simon R, Konstantopolos N, Blackwelder WC, Barry EM and Pasetti MF. Bioactive Immune Components of Anti-Diarrheagenic
Enterotoxigenic Escherichia coli Hyperimmune Bovine Colostrum products. Clinical and Vaccine Immunology. 24 (8) 1-14; 2017.
R. Epidemiology of travelers' diarrhea. J Travel Med. 24(suppl_1): S2-S5; 2017.
more information visit: https://www.immuron.com.au/ and https://www.travelan.com
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