US Department of Defense Uniformed Services University Clinical Evaluation of Travelan™ Achieves 150 Recruitment Milestone
January 18 2023 - 5:00AM
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 provide
shareholders and the market with a progress update on the US
Department of Defense Uniformed Services University (USU) Clinical
Evaluation of Travelan.
After overcoming significant challenges due to
the COVID-19 pandemic and international travel restrictions and
COVID-19 related quarantine period enforced by many countries the
USU has reported that to date it has successfully recruited 157
participants into the clinical study following the initiation of
enrolment (ASX announcement 9 May 2022). USU expect to complete
clinical trial enrolment in approximately 18 months.
USU’s Infectious Diseases Clinical Research
Program (IDCRP), the UK Ministry of Defense and the New York City
Travel Clinic are jointly conducting the randomized clinical trial
to evaluate the efficacy of Travelan and a commercially available
probiotic nutraceutical product in Travelers’ Diarrhea. The P3TD
study is a randomized, double-blind, placebo controlled multicenter
clinical trial designed to evaluate the effectiveness of IMM-124E
(Travelan®) passive immunoprophylaxis and Florastor® verses a
placebo, during deployment or travel to a high-TD risk region
(ClinicalTrials.gov Identifier: NCT04605783). All study
participants (1302 in total) will be randomized to Travelan®,
Florastor® or placebo (434 per arm).
The
Problem: Travelers’ diarrhea (TD) remains a highly
prevalent disease that impacts operational readiness of military
personnel and is also debilitating civilian travel. In addition to
its acute morbidity, TD is associated with acquisition of
antimicrobial resistance genes and long-term sequelae. Current
mitigation strategies including pre-travel counseling and
antibiotics for prevention and treatment have important
limitations, and there are currently no licensed, pathogen-specific
vaccines for TD prevention.
The Approach: Prebiotics,
probiotics and passive immunotherapy may offer safe and relatively
inexpensive preventive strategies by promoting gut resistance to
enteropathogens, and potentially lessening the use of antibiotics.
USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK
Ministry of Defense and the New York City Travel Clinic are jointly
conducting a randomized clinical trial to evaluate the efficacy of
these nutraceutical products for TD prevention and inform
strategies for Force Health Protection.
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 infectious
diseases.
For more information visit:
http://www.immuron.com
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