US Department of Defense Uniformed Services University Clinical Evaluation of Travelan™ Achieves 150 Recruitment Milestone

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has enrolled its first participants in the USU Travelan Clinical Trial Field Study, successfully randomizing 157 participants out of a target of 1302 volunteers. This clinical trial, conducted by USU's Infectious Diseases Clinical Research Program in partnership with the UK Ministry of Defense and the New York City Travel Clinic, aims to evaluate the efficacy of Travelan against Travelers’ Diarrhea. The study, designed to assess passive immunotherapy, is set to complete enrollment in roughly 18 months. Travelers' diarrhea poses significant health risks, especially for military personnel, highlighting the need for effective preventative strategies.

Positive

• Enrollment of 157 participants indicates strong progress toward the target of 1302 volunteers.
• Study aims to address a significant health issue, potentially improving operational readiness for military personnel.

Negative

• Currently no FDA-approved vaccines for Travelers’ Diarrhea exist, indicating a gap in effective prevention methods.

Highlights:

• 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.

COMPANY CONTACT:

Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com   

About Immuron
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

FAQ

What is the status of the Travelan Clinical Trial for IMRN?

The Travelan Clinical Trial has enrolled 157 participants, with plans to enroll a total of 1302 volunteers.

What is the goal of the Travelan Clinical Trial by IMRN?

The trial aims to evaluate the efficacy of Travelan in preventing Travelers’ Diarrhea.

When is the expected completion date for the Travelan Clinical Trial?

The enrollment is expected to be completed in approximately 18 months.

Who is conducting the Travelan Clinical Trial for IMRN?

The trial is being conducted by USU's Infectious Diseases Clinical Research Program, alongside the UK Ministry of Defense and the New York City Travel Clinic.

What health issue does the Travelan Clinical Trial address for IMRN?

The trial addresses the high prevalence of Travelers’ Diarrhea, particularly among military personnel.