Full Press Release Details
Immuron receives approval from U.S. Army Medical Research and Development Command
Recruitment and screening of healthy volunteers for Travelan® Controlled Human Infection Model (CHIM) Clinical Trial is in progress
Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military will commence shortly
Travelan® is known to protect against the onset of Travelers diarrhea (TD), the most common illness reported by travelers
This is one of three Phase 2 studies with FDA IND approval to proceed; in addition to a clinical trial of Travelan® in progress by the Uniformed Services University
MELBOURNE, Australia, May 30, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that it has received approval from the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).
The study has also been granted Institutional Review Board (IRB) human ethics and US Food and Drug Administration (FDA) approvals (ASX announcement December 23, 2022).
Immuron is now proceeding with the planned clinical trial in the United States and has initiated recruitment.
The clinical study will be conducted by Pharmaron CPC at its FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase II clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea.
This week Pharmaron initiated recruitment of up to 60 healthy participants (males or non-pregnant, non-nursing females), aged 18-50 years on the Pharmaron Website.
The first cohort of 30 participants is anticipated to be enrolled and dosed by the end of July 2023. The final 30 participants are anticipated to be enrolled into the study in October 2023. Headline results from the clinical trial expected to be reported in 1H 2024.
This is one of four clinical trials Immuron has, or is soon to, initiate. The U.S. Department of Defense Uniformed Services University is running a randomized clinical trial of Travelan® in up to 868 participants (ASX announcement January 18, 2023). ClinicalTrials.gov Identifier: NCT04605783.
The FDA recently removed a clinical hold on two planned Phase 2 trials of Campylobacter ETEC therapeutic paving way for initiation (ASX announcement May 8, 2023).
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 inflammatory mediated and infectious diseases.
For more information visit: http://www.immuron.com