Immuron Announces Travelan® Clinical Study Cohort 2 commences
2023年10月18日 - 7:00PM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company, is pleased to
announce the second cohort of 34 participants have commenced the
clinical trial to evaluate the efficacy of Travelan® to prevent
infectious diarrhea caused by enterotoxigenic Escherichia coli
(ETEC).
The clinical study is being led by Principal
Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA
inspected Clinical Research Facility Inpatient Unit located in
Baltimore, Maryland US. The Phase 2 clinical trial is designed to
evaluate the safety and protective efficacy of Travelan® 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: NCT05933525.
The first cohort in-patient stage of the study
was completed in August 2023. Immuron received confirmation that a
second cohort of 34 study participants were admitted to the
Pharmaron inpatient facility and randomized to receive either
Travelan® or placebo. The inpatient phase for the second cohort
will be completed by the end of October 2023. All study
participants will return as outpatients for 2 weeks, 1 month and 6
month follow-up visits. Headline results from the clinical trial
are anticipated to be reported in June 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
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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から 6 2023 まで 6 2024