US DoD Uniformed Services University Travelers’ Diarrhea Clinical Update

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced a clinical trial program to evaluate the efficacy of Travelan® and two non-antibiotic OTC products for Travelers' Diarrhea. The Uniformed Services University (USU) commenced manufacturing investigational products in November 2021, anticipating enrollment to start in April 2022. The trial aims to enroll 1,336 participants over 18 months, assessing three nutraceuticals against a placebo. This initiative involves collaboration with USU’s Infectious Diseases Clinical Research Program and other organizations to enhance health strategies for travel risk.

Positive

• Initiation of a clinical trial program for Travelers' Diarrhea with significant partnership.
• Manufacturing of investigational products commenced in November 2021.
• A total of 1,336 participants planned for enrollment, indicating robust trial design.

Negative

• None.

Key Points

• Manufacture of investigational medical products to support the Uniformed Services University (USU) clinical program to evaluate the efficacy of Travelan® and two other non-antibiotic OTC products in Travelers’ Diarrhea initiated
• USU are anticipating an enrolment start date of April 2022 and plan to enrol 1336 participants in total

MELBOURNE, Australia, Nov. 15, 2021 (GLOBE NEWSWIRE) --  Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today is pleased to provide shareholders and the market with an update on the planned clinical trial program to evaluate the efficacy of Travelan® and two other non-antibiotic OTC products in Travelers’ Diarrhea sponsored by the Uniformed Services University of the Health Sciences (USU).

USU have initiated the manufacturing campaign to produce the first batches of investigational medical products in November 2021 to support the planned clinical trial program to evaluate the efficacy of Travelan® and two other dietary supplement products in Travelers’ Diarrhea. USU are anticipating an enrollment start date of April 2022 for the planned clinical trial and are hoping to complete enrollment 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 planning to conduct the randomized clinical trial to evaluate the efficacy of three nutraceutical products for TD and inform strategies for Defense Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 commercially available nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM-124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783).

All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm).

This release has been authorised by the directors of Immuron Limited.

COMPANY CONTACT: Dr Jerry Kanellos, Ph.D. Chief Executive Officer Ph: +61 (0)3 9824 5254 info@immuron.com

For more information visit: http://www.immuron.com

FAQ

What is the purpose of Immuron's clinical trial for IMRN?

The trial aims to evaluate the efficacy of Travelan® and two other non-antibiotic OTC products in preventing Travelers' Diarrhea.

When is the enrollment for the Travelers' Diarrhea trial expected to begin?

Enrollment for the trial is anticipated to start in April 2022.

How many participants will be involved in the IMRN clinical trial?

The trial plans to enroll a total of 1,336 participants.

What products are being tested in the Travelers' Diarrhea clinical trial?

The trial will test Travelan®, Bimuno®, and Florastor® against a placebo.