Immuron Ltd. Highlights Market Opportunity Following Recent Studies on Antibiotic Correlation to C. Difficile Infections

MELBOURNE, Australia, Oct. 17, 2017 (GLOBE NEWSWIRE) -- Immuron Limited (ASX:IMC) (NASDAQ:IMRN), an Australian microbiome biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the treatment of gut-mediated diseases, today highlighted recent results from multiple independent studies that address the challenge of utilizing antibiotics as a ‘one size fits all’ approach to treating and preventing various forms of infection.

One study performed by the Minnesota Department of Health on antibiotic prescribing for dental procedures in community-associated clostridium difficile cases, which was presented at ID Week 2017, focused on the impact of antibiotic prescription from dentists and the correlation to C. diff infection rates. Per MedPage Today, “Analysis of 7 years of surveillance data in five Minnesota counties found that 57% of C. difficile patients had been prescribed antibiotics, something that was assumed to be the cause of the disease,” according to Stacy Holzbauer... “but 15% of those patients were given the drugs by their dentists. In many cases that fact didn't find its way into the patient's primary care records.”

Another study, found in the American Journal of Infection Control, focused on the impact of electronic sepsis initiatives on antibiotic use and health care facilities, and the correlation to C. diff infection rates. Per Contagion Live, “the investigators found that there was an increase in antibiotic use with the implementation of the sepsis program, with the highest rate of antibiotic use of 50.4 days of therapy per 1,000 patient days occurring directly after the implementation of the program” and that the rate rose to 10.8 infections per 10,000 patient days per month following the program’s implementation.

Antibiotics are an increasingly used solution for both the treatment and prevention of a variety of infections resulting in the elimination of both good and bad bacteria. However, this failure to nurture the microbiome through the reintroduction of good bacteria leaves patients susceptible to ailments, including prominently C. diff. Medical associations including the Centers for Disease Control and Prevention (CDC) have highlighted the importance of developing new treatments, including the need for improved antibiotic use and infection control as C. diff infects more than 450,000 patients causing over 29,000 deaths per year in the United States alone.

This demand for non-antibiotic solutions creates a new market opportunity for Immuron’s IMM-529 compound and its unique mechanism of action that targets harmful bacteria without negatively impacting the microbiome. IMM-529 uses a combination of polyclonal antibodies to target and neutralize the main virulence factors of C. diff. The drug is designed to treat and prevent C. diff by targeting the spores and vegetative cells that are thought to be the primary cause of the recurrences, alongside the Toxin B which is targeted by most therapeutics in development today.

“It is becoming increasingly clear following recent academic studies that overuse and unnecessary prescriptions of antibiotics are resulting in higher rates of C. diff,” said Jerry Kanellos, CEO of Immuron Ltd. “As antibiotics are a staple in medical facilities, the need for a drug candidate that effectively treats C. diff has significant value within the healthcare community, including hospitals and outpatient facilities, such as a dentist office. For this reason, we are hopeful that IMM-529 will continue its steady progression and positive trial results, hopefully reaching doctors and their patients to establish a new, effective treatment for C. diff."

About IMM-529:
IMM-529 is an oral compound taken three times per day consisting of a combination of polyclonal antibodies targeting the Clostridium-Difficile's toxin B responsible for the clinical manifestation of the disease, as well as the spores and the vegetative cells which are thought to be the primary cause of the recurrences. The delivery of IMM-529 results in localized toxin B neutralization, while binding to the C-Diff spores and vegetative cells to prevent further colonization. IMM-529 antibodies have been shown to survive transit through the stomach and remain functional up through the large intestine. 

In addition, the antibodies in IMM-529 have demonstrated to cross-react 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 the worldwide outbreaks in 2011.

In preclinical studies, IMM-529 demonstrated superiority in prophylactic use, treatment of disease, and the prevention of recurrence. All results were published in the Nature Journal Scientific Reports earlier this year (Hutton et al Scientific Reports 2017;7:3665).

About CDI:
Clostridium difficile is the causative organism of antibiotic-associated colitis. Colonization is facilitated by disruption of normal intestinal flora due to antimicrobial therapy. The organism is capable of elaborating exotoxins that bind to receptors on intestinal epithelial cells, leading to inflammation and diarrhea and, in severe cases, death. Clostridium difficile Infection (CDI) has become a major-medical concern causing an estimated annual economic burden of more than US$10 billion globally.  The problem is especially acute in hospitals and in long-term in-patient care facilities.  Over 453,000 cases of recurrence are recorded annually while an estimated 29,300 patients die each year from CDI infections in the USA alone (* CIDRAP Center for Infectious Disease Research and Policy (Feb 2015)).

     
COMPANY CONTACT:
Jerry Kanellos
Chief Executive Officer
Ph: +61 (0)3 9824 5254
jerrykanellos@immuron.com
 AUS INVESTOR RELATIONS:
Peter Taylor
NWR Communications
Ph: +61 (0)4 1203 6231
peter@nwrcommunications.com.au
 USA MEDIA CONTACT:
Kate Caruso-Sharpe
FischTank Marketing and PR
Ph: + 1 646 699 1414
kate@fischtankpr.com
     

ABOUT IMMURON:
Immuron Ltd (ASX:IMC) is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the treatment of many gut mediated diseases.  Immuron has a unique and safe technology platform that enables a shorter development therapeutic cycle.  The Company currently markets and sells Travelan® for the prevention of travellers’ diarrhea whilst its lead product candidate IMM-124E is in Phase 2 clinical trials for NASH and ASH.  These products together with the Company’s other preclinical immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in the market.  For more information visit: http://www.immuron.com

FORWARD-LOOKING STATEMENTS:
Certain statements made in this release are forward-looking statements and are based on Immuron’s current  expectations,  estimates and  projections.  Words such  as  “anticipates,”  “expects,”  “intends,”  “plans,”  “believes,”   “seeks,”   “estimates,”   “guidance”   and   similar expressions  are intended to identify forward-looking statements. Although Immuron believes the forward-looking statements are based on   reasonable  assumptions,   they   are   subject   to   certain   risks   and   uncertainties,   some  of  which  are  beyond  Immuron’s  control, including  those  risks  or  uncertainties  inherent  in  the  process  of  both  developing  and  commercialising technology. As a result, actual results could materially differ   from   those   expressed   or   forecasted   in   the   forward-looking   statements. The forward-looking statements made in this release relate only to events as  of  the  date  on  which  the  statements  are  made.  Immuron will not undertake  any obligation  to  release  publicly  any  revisions   or   updates   to   these   forward-looking   statements   to   reflect   events,   circumstances   or unanticipated  events  occurring  after  the date of this release except as required by law or by any appropriate regulatory authority.

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