Full Press Release Details
Immuron Submits IMM-529 IND to FDA
Melbourne, Australia, October 8, 2025: Immuron
Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce that it has submitted an Investigational New Drug (IND) application to the United
States Food and Drug Administration (FDA) for clinical development of IMM-529. Under this new IND, Immuron is proposing the development
of IMM-529 for treatment of Clostridioides difficile (C. diff) infection (CDI) and prevention of recurrent CDI (rCDI).
The Company plans to initiate a Phase 2 clinical
trial for IMM-529 in individuals with Clostridioides difficile infection (CDI) during the first half of 2026.
Independent Market analysis conducted by Lumanity
suggests that, pending demonstration of efficacy, IMM-529 could be positioned at the earliest point in the treatment algorithm permitted
by payer guidelines. The Phase 2 clinical trial is expected to enroll both first episode and recurrent CDI patients. The estimated eligible
population of patients would be approximately 98,000 individuals if IMM-529 is introduced as a treatment at the first recurrence stage.
Considering market size, anticipated payer dynamics,
competitive landscape, and pricing assumptions, base case annual revenue potential for IMM-529 is projected at approximately US$400M.
Additionally, the oral administration route has been positively received by infectious disease specialists, reinforcing IMM-529's
clinical and commercial appeal.
The increased incidence of antibiotic resistant
superbugs' has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment
is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile
(C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy
reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI.
C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease
Control and Prevention's report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people
in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent
call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.
To address this need, Immuron is developing IMM-529
as an adjunctive therapy in combination with standard of care antibiotics for the treatment of CDI and prevention recurrent CDI. IMM-529
has been designed with antibodies that target the key essential virulence components of C. diff, with the potential to accelerate the
clearance of CDI infection and support rapid restoration of healthy gut microbiota. This mechanism of action positions IMM-529 as a compelling
oral therapeutic drug candidate for the treatment of CDI and preventative of disease recurrent CDI, addressing a critical unmet need in
infectious disease management.Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines
designed to elicit antibodies against essential C. diff virulence components. IMM-529 specifically targets Toxin B (TcB),
the spores, and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).
This novel 3-target approach has yielded promising
results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection
of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529
antibodies cross-react with whole cell lysates of many different human and animal strains of C. diff including hypervirulent strains.
To our knowledge, IMM-529 is, to date, the only
investigational drug that has shown therapeutic potential in all three phases of the disease. https://doi.org/10.1038/s41598-017-03982-5
This release has been authorised by the directors
Chief Executive Officer
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 infectious diseases.
Immuron's 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.
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