Immuron Receives FDA Approval for Travelan IND Application
December 23 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 received approval from the US Food and Drug Administration to
proceed with the clinical evaluation of Travelan. The
Investigational New Drug (IND) application to evaluate the efficacy
of a single dose of Travelan to prevent infectious diarrhea caused
by ETEC is now active.
As a result of this approval the company will
proceed with the planned clinical trial in the United States. The
safety and protective efficacy of Travelan will be tested utilizing
a controlled human infection-model clinical trial design.
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.
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). Recruitment is planned to be initiated in 1H
2023 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
For more information visit:
http://www.immuron.com
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