Immuron Plans Phase 3 trial for IMM-124E to Prevent Travelers’ Diarrhea
November 21 2019 - 7:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunoglobulin therapeutics for the treatment of gut mediated
diseases, today announced that the company recently completed a
Pre-IND meeting with the U.S. Food and Drug administration (FDA)
regarding its investigational drug IMM-124E which the company is
developing to treat travelers’ diarrhea (TD). Following the
FDA’s guidance and feedback, the Company now plans to file an
investigational new drug (IND) application for IMM-124E to prevent
TD during the first half of 2020, followed by a Phase 3 trial of
IMM-124E to prevent TD in individuals traveling to areas where TD
is endemic.
“We already have a great deal of clinical experience with
IMM-124E due to an earlier clinical trial the Company conducted
with this drug candidate in a clinical study in patients with
nonalcoholic steatohepatitis under a separate IND,” said Dr. Gary
S. Jacob, CEO of Immuron Ltd. “Our recent interactions with
FDA were exceedingly helpful in refining plans for this Phase 3
trial. To our knowledge, IMM-124E, once successfully shown to
work in subjects traveling to endemic areas, and successfully
approved, would be the first and only FDA-approved pharmaceutical
product to specifically prevent diarrhea.”
Travelan® and IMM-124E, Immuron’s drug candidate presently in
clinical development for TD, are one and the same active
pharmaceutical ingredient. The Company currently markets and sells
Travelan® as a Therapeutic Goods Administration (TGA) listed
medicine for prevention of TD in Australia, and also markets
Travelan® in the U.S. and Canada as a dietary supplement, and
natural health product, respectively, for digestive tract
protection.
ABOUT IMM-124EIMM-124E is a first-in class,
oral polyclonal antibody therapy currently being developed as a
prophylactic treatment to prevent TD in individuals traveling to
endemic areas for ETEC exposure. In an earlier study
completed in 133 biopsy-proven NASH patients where patients were
treated with either IMM-124E or placebo for 6 months, treatment
with IMM-124E resulted in a statistically significant reduction of
serum LPS levels when compared to placebo. In addition, biomarkers
associated with inflammation were also reduced by IMM-124E
including ALT, AST and cytokeratin-18. IMM-124E was developed to
target the endotoxin lipopolysaccharide (LPS) and other pathogenic
bacterial components in the human gastrointestinal tract to
potentially reduce LPS-related inflammation and systemic
translocation.
ABOUT TRAVELAN®Travelan® is a highly purified
tabletized preparation of hyper-immune bovine antibodies and other
factors, which when taken with meals is believed to bind to
diarrhea-causing bacteria, preventing colonization and the
pathology associated with TD. 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 TD, 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 TD. In the U.S.,
Travelan® is sold as a dietary supplement for digestive tract
protection.
ABOUT TRAVELERS’ DIARRHEATravelers’ diarrhea
(TD) affects between 30 and 70% of over one billion international
travelers every year. TD 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 TD as they may be contracted while travelling and initial
symptoms are often indistinguishable.
ABOUT IMMURONImmuron Limited
(ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical
company focused on developing and commercializing orally delivered
targeted polyclonal antibodies for the treatment of inflammatory
mediated and infectious diseases. Immuron has a novel technology
platform with one commercial asset Travelan® generating revenue.
Immuron’s lead clinical candidate, IMM-124E, is presently being
developed as a drug to prevent TD. The Company also has a
collaborative program with the U.S. Department of Defense (DoD) to
develop treatments utilizing the Company’s hyperimmune bovine
colostrum technology against enteric acute infectious pathogens,
including Shigella and Campylobacter. A recent USD $3.7
million grant was awarded by DoD to develop a product against
Campylobacter utilizing this technology. Immuron’s second
clinical-stage asset, IMM-529, targets Clostridium difficile
Infections (CDI). These products together with the Company’s other
preclinical pipeline products currently under development targeting
immune-related and infectious diseases are anticipated to meet
pressing needs in the global immunotherapy market.
For more information visit:
http://www.immuron.com
COMPANY CONTACT: Gary S. Jacob,
Ph.D.Chief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com |
AUS INVESTOR RELATIONS: Peter
TaylorNWR CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
USA INVESTOR RELATIONS: Dave Gentry -
CEO RedChip Companies, Inc. US Ph: +1 (407) 491 4498
dave@redchip.com |
For more information visit: http://www.immuron.com.
FORWARD-LOOKING STATEMENTS:
This press release may contain “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, each as
amended. Such statements include, but are not limited to, any
statements relating to our growth strategy and product development
programs and any other statements that are not historical facts.
Forward-looking statements are based on management’s current
expectations and are subject to risks and uncertainties that could
negatively affect our business, operating results, financial
condition and stock value. Factors that could cause actual results
to differ materially from those currently anticipated include:
risks relating to our growth strategy; our ability to obtain,
perform under and maintain financing and strategic agreements and
relationships; risks relating to the results of research and
development activities; risks relating to the timing of starting
and completing clinical trials; uncertainties relating to
preclinical and clinical testing; our dependence on third-party
suppliers; our ability to attract, integrate and retain key
personnel; the early stage of products under development; our need
for substantial additional funds; government regulation; patent and
intellectual property matters; competition; as well as other risks
described in our SEC filings. We expressly disclaim any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as
required by law.
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