Full Press Release Details
Receives U.S. Patent on Drug Composition to Treat Clostridium difficile
Provides Update on Status of IMM-529 Clinical Trial and New Strategic Focus
Australia, March 19, 2019: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing
and commercializing oral immuno-therapeutics for the treatment of gut mediated diseases, today
announced the issuance of a patent by the United States Patent and Trademark Office (USPTO) for
a method to treat Clostridium difficile infections. The patent (USPTO No. 10144775) entitled "Methods
and compositions for the treatment and/or prophylaxis of Clostridium difficile associated disease" describes
a targeted drug composition comprising an enriched, hyperimmune polyclonal antibody preparation of bovine colostrum for use in
treating C. difficile, a bacterium that causes life threatening diarrhea. The Company's drug candidate IMM-529,
which is based on this technology, is presently in a Phase 1/2a clinical trial in C. difficile patients.
claims of this new U.S. patent provide broad coverage of the application of our proprietary technology to the treatment of C.
difficile Infection (CDI)," said Gary S. Jacob, Ph.D., CEO of Immuron Ltd. "CDI remains a major-medical problem
causing an estimated annual economic burden of more than USD $10 billion globally. The problem is especially acute in hospitals
and in long-term in-patient care facilities. Moreover, the problem is compounded by the high rate of recurrence in patients treated
with front-line antibiotics. Immuron's drug candidate IMM-529 is not an antibiotic. It is comprised of a hyperimmune polyclonal
antibody colostrum agent that is capable of binding and inactivating not only the C. difficile toxin B but also spore antigens
and vegetative cell antigens. We plan to focus our efforts moving forward on developing IMM-529 to treat patients with recurrent
C. difficile with the filing of an IND with FDA. This will enable us to include clinical sites in the U.S. as well as in
the rest of the world."
phase I/IIa clinical trial of IMM-529 in patients with C. difficile presently being conducted in two clinics in Israel
has not met the patient enrolment numbers which the Company anticipated. As a result, Immuron has addressed this issue by making
changes to the current enrolment protocol. A feasibility and Australian-site identification process is now complete, and the Company
expects to have Australian clinical sites open for recruitment of patients shortly. The Company's strategic plan to file
an IND with FDA, to further develop the drug candidate and to specifically focus on treating patients with recurrent disease,
is intended to pursue a major unmet medical need in treatment of patients suffering with C. difficile infections, as well
as significantly enhance patient enrolment by adding sites located in the U.S.
Clostridium difficile
difficile is a Gram-positive, spore-forming, anaerobic bacterium that infects the gastrointestinal tract and causes an array
of clinical symptoms ranging from mild diarrhoea to more severe, often fatal, gastrointestinal disease such as pseudomembranous
colitis and toxic megacolon. The infection cycle of C. difficile is complex because this bacterium produces spores
that are highly resistant to environmental assaults, enabling persistence in unfavourable environments. Spores are the infectious
particles ingested by the host, where they germinate into vegetative cells, colonise the large intestine and establish infection.
The bacteria produce toxins causing inflammation of the colon resulting in severe diarrhea and, in
severe cases, death. An estimated 28,000 patients die each year from CDI infections in the USA alone, while recurrent CDI affects
~100,000 people in the U.S. annually. C. difficile infection is most often associated with antibiotic use as the
alteration to the endogenous gastrointestinal microbiota results in increased susceptibility to CDI. Paradoxically, the standard
of care treatment of (CDI) also involves antibiotic use, leaving patients susceptible to re-infection.
is a polyclonal antibody biological product intended to prevent and treat C. difficile infections and has been developed
to spare the gut microbiome from the effects of "classic" antibiotic treatments. The delivery of IMM-529 results in
localized toxin B neutralization at the site of infection and prevents severe damage occurring to the gut while also binding to
C. difficile spores and vegetative cells preventing further colonization. In addition, the antibodies in IMM-529 have demonstrated
cross-reactions with a variety of human and animal C. difficile isolates and their associated Toxin B, vegetative cell
and spore components. The antibodies in IMM-529 have also been shown to neutralize Toxin B from a historical C. difficile
strain (630) and from a hypervirulent (HV) strain which caused a worldwide outbreak of the disease.
Limited (ASX: IMC, NASDAQ: IMRN), is an Australian microbiome biopharmaceutical company focused on developing and commercializing
orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron has
a unique and safe technology platform that enables a shorter development therapeutic cycle. The Company currently markets Travelan
in Australia for the prevention of Travelers' Diarrhea, and markets Travelan in the U.S. and Canada as a dietary supplement
for digestive tract protection. Immuron's lead clinical candidate, IMM-124E, is presently in Phase II trials in Severe Alcoholic
Hepatitis (SAH) and Pediatric Nonalcoholic Fatty Liver Disease (NAFLD). Immuron's second clinical-stage asset, IMM-529,
targets Clostridium difficile Infections (CDI), and is presently in a clinical trial in C. difficile patients.
more information visit: http://www.immuron.com.
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