US Department of Defense Uniformed Services University Clinical Evaluation of Travelan™ Achieves 150 Recruitment Milestone
- First participants enrolled in USU Travelan Clinical Trial Field Study
- 157 participants successfully randomized into the Clinical Study
- Plans in place to enrol in 1302 healthy volunteers in total
- Infectious diarrhea is the most common illness reported by travelers & military personnel
MELBOURNE, Australia, Jan. 18, 2023 (GLOBE NEWSWIRE) -- 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.
Chief Executive Officer
Ph: +61 (0)3 9824 5254
Immuron 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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