Full Press Release Details
US DoD Naval Medical Research Center Requests Meeting
FDA for Guidance on two Phase 2 trials to Prevent Acute
Melbourne, Australia, June 9, 2020: Immuron
Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics
for the prevention and treatment of gut mediated pathogens, today is pleased to provide shareholders with an update on the company's
research collaboration with the Naval Medical Research Center (NMRC) to develop and clinically
evaluate a new therapeutic against campylobacter and ETEC (E-Coli). The NMRC recently
requested a Pre-IND meeting with the U.S. Food and Drug administration (FDA) regarding its new investigational drug which the company
is developing to treat moderate to severe campylobacteriosis and ETEC infections.
The FDA on the 26 May 2020 issued guidance
explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain
user fee-funded applications. The FDA will focus its resources on applications and submissions related to Covid-19 and other life-threatening
conditions. The FDA will still aim to conduct initial investigational new drug application (IND) 30-day safety reviews and respond
to "other important safety issues that may emerge during IND development". The agency will provide written comments
on the non-clinical information in the Pre-IND information package which is planned to be submitted on the 10th of June 2020. Following
the FDA's guidance and feedback, the NMRC plans to file an investigational new drug (IND) application later this year and
commence the Phase 2 clinical studies during the first half of 2021.
"We received a formal start work notification and approval
at the end of January 2020 from the Henry Jackson Foundation for the Advancement of Military Medicine to commence work on the sub
award" said Dr. Jerry Kanellos, CEO of Immuron Ltd.
"The Australian Importation permit
required to ship the vaccines from the NMRC was approved by Biosecurity Australia and the NMRC vaccines were shipped to our contract
research partner to commence the project. The COVID-19 pandemic put the brakes on this and all our research and development activities.
We have been monitoring the situation closely and I am please to say with the easing of restrictions around Australia work on the
development of the clinical product can now recommence. The plan is to have the product completed by the end of this year and have
it ready for clinical evaluation next year."
The COVID-19 pandemic has also impacted
the IMM-124E pediatric clinical study in Nonalcoholic Fatty Liver Disease. The study's Principle Investigator Dr Miriam Vos
from the Emory University School of Medicine closed the study earlier this year with only 22 subjects out of a target 40 completed
the study protocol. The study findings were reported as negative as there was no substantial changes in ALT (Primary study end
point) in the active arm of the study when compared to placebo.
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.
About Travelers' diarrhea
diarrhea 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 travelers' diarrhea as they may be contracted while travelling and initial symptoms are
often indistinguishable.
(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 and safe
technology platform with one commercial asset generating revenue. In Australia, Travelan is a listed medicine on the Australian
Register of Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travellers' Diarrhea, reduce the risk
of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan is a licenced natural health product (NPN 80046016)
and is indicated to reduce the risk of Travellers' Diarrhea. In the U.S., Travelan is sold as a dietary supplement for
digestive tract protection in accordance with section 403 (r)(6) of the Federal Drug Administration (FDA).
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.