Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical Study
December 04 2023 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company is pleased to
announce that the US Naval Medical Research Command (NMRC) has
initiated the clinical evaluation of a new oral therapeutic
targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC)
developed in collaboration with Immuron. The NMRC has prioritized
the clinical development of the study to evaluate the efficacy of
the new therapeutic product to prevent infectious diarrhea caused
by Campylobacter.
The clinical study is being led by Principal
Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University
(JHU) Center for Immunization Research (CIR) Inpatient Unit,
located at the JHU Bayview Medical Campus, Baltimore, Maryland.
U.S. The Phase 2 clinical trial is designed to evaluate the safety
and protective efficacy of the new product compared to a placebo in
a controlled human infection model (CHIM). The primary efficacy
outcome is prevention and/or reduction of moderate to severe
diarrhea. ClinicalTrials.gov Identifier: NCT06122870.
The dosing, challenge and the in-patient stage
of the study is anticipated to be completed by the third week of
December 2023. The estimated study completion date (last
participant, last visit) is June 2024 with headline results from
the clinical trial expected to be reported in 2H 2024.
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 demonstrated increasing resistance to commonly
prescribed antibiotics. In addition, traveler’s diarrhea is now
recognized by the medical community to result in post-infectious
sequelae, including post-infectious irritable bowel syndrome (IBS)
and several post-infectious autoimmune diseases. A preventative
treatment that defends against infectious 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 Travelers’ diarrhea
Travelers’ 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.
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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