US DoD Uniformed Services University Travelers’ Diarrhea Clinical Update

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.

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