Immuron Submits IND Application To FDA for Travelan
December 05 2022 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company that has developed
two commercially available oral immunotherapeutic products for the
treatment of gut mediated diseases, is pleased to announce that it
has submitted an Investigational New Drug (IND) application to the
US Food and Drug Administration for Travelan®.
The Phase II clinical trial will evaluate the
efficacy of a single dose regimen of Travelan® in a controlled
human infection model (CHIM) using the enterotoxigenic Escherichia
coli (ETEC) strain H10407. The clinical study aims to enrol up to
60 healthy adult subjects each will be randomly assigned to receive
either a once-daily dose of 1200 mg of Travelan® (30 subjects) or
placebo (30 subjects).
Immuron is the sponsor of the IND, and the
clinical study will be conducted by the Contract Research
Organisation Pharmaron CPC, Inc (ASX announcement October 4, 2022)
at its FDA inspected clinical research facility located in
Baltimore, Maryland in the USA . Dr. Mohamed Al-Ibrahim, MB, ChB,
FACP will be the Principal Investigator for the study with
recruitment planned to commence in 1H 2023 subject to FDA approval
with headline results from the clinical trial expected to be
reported by year end 2023.
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and among US
troops deployed overseas. The morbidity and associated discomfort
stemming from diarrhea decreases daily performance, affects
judgment, decreases morale and declines operational readiness. The
first line of treatment for infectious diarrhea is the prescription
of antibiotics. Unfortunately, in the last decade, several enteric
pathogens have an increasing resistance to commonly prescribed
antibiotics. In addition, travelers' diarrhea is now recognized by
the medical community to result in post-infectious sequelae,
including post-infectious Irritable Bowel Syndrome and several
post-infectious autoimmune diseases. A preventative treatment that
protects against enteric diseases, is a high priority objective for
the US Military.
This release has been authorised by the
directors of Immuron Limited.
COMPANY
CONTACT:Steven LydeamoreChief Executive
OfficerPh: +61 (0)3 9824 5254info@immuron.com
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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.
For more information visit:
http://www.immuron.com
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