Ann: Immuron Receives FDA Approval for Travelan IND Application, page-2

Things do not move very quickly in the US of A, unless you want to bomb another country of course.. 12 months of trials coming up, when you would really know in a week if you had taken the placebo.

Oh well, Merry Christmas all in here, lets hope next year is slightly more productive..

Just an opinion,

TCG

Highlights: • Immuron receives U.S. Food and Drug administration (FDA) approval for Travelan Investigational New Drug (IND) application
• IND to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active
• Plans in place to initiate a Human clinical trial in 60 healthy volunteers in the USA
• Clinical Trial to examine a dosing regimen for Travelan more suited for use by the US military
• Infectious diarrhea is the most common illness reported by travelers

Melbourne, Australia, December 23, 2022: 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 announce that it has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of Travelan. The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active. As a result of this approval the company will proceed with the planned clinical trial in the United States. The safety and protective efficacy of Travelan will be tested utilizing a controlled human infectionmodel clinical trial design. Immuron is the sponsor of the IND, and the clinical study will be conducted by the Contract Research Organisation Pharmaron CPC, Inc (ASX announcement October 4, 2022) at its FDA inspected clinical research facility located in Baltimore, Maryland in the USA. The Phase II clinical trial will evaluate the efficacy of a single dose regimen of Travelan® in a controlled human infection model (CHIM) using the enterotoxigenic Escherichia coli (ETEC) strain H10407. The clinical study aims to enrol up to 60 healthy adult subjects each will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® (30 subjects) or placebo (30 subjects). Recruitment is planned to be initiated in 1H 2023 with headline results from the clinical trial expected to be reported by year end 2023.