Immuron Submits IND Application To FDA for Travelan

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has submitted an Investigational New Drug (IND) application to the U.S. FDA for its product Travelan®. A Phase II clinical trial is set to evaluate a single dose regimen of Travelan® in a controlled human infection model, targeting infectious diarrhea caused by the enterotoxigenic Escherichia coli. The trial will involve 60 healthy subjects receiving either Travelan® or a placebo. Results are anticipated by the end of 2023, aligning with the U.S. military's need for preventative treatments against gastrointestinal diseases in troops.

Positive

• IND application submitted to the FDA for Travelan®.
• Phase II clinical trial planned with 60 healthy volunteers.
• Targeting a high-priority need for the US military regarding infectious diarrhea.

Negative

• None.

Highlights:

• Investigational New Drug (IND) application submitted to the U.S. Food and Drug administration (FDA)
• 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, Dec. 05, 2022 (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 announce that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for Travelan®.

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).

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 . Dr. Mohamed Al-Ibrahim, MB, ChB, FACP will be the Principal Investigator for the study with recruitment planned to commence in 1H 2023 subject to FDA approval with headline results from the clinical trial expected to be reported by year end 2023.

Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have an increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases, is a high priority objective for the US Military.

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 inflammatory mediated and infectious diseases.

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

FAQ

What is the purpose of the IND application submitted by Immuron (IMRN)?

The IND application aims to evaluate Travelan® for preventing infectious diarrhea in a Phase II clinical trial.

When will the clinical trial for Travelan® begin?

Recruitment for the clinical trial is planned to commence in 1H 2023, subject to FDA approval.

What are the expected results timeline for the Travelan® clinical trial?

Headline results from the clinical trial are expected to be reported by the end of 2023.

Who is conducting the clinical trial for Travelan®?

The clinical trial will be conducted by Pharmaron CPC, Inc at its FDA inspected facility in Baltimore, Maryland.

What health issue does Travelan® aim to address?

Travelan® aims to address infectious diarrhea, which is a common illness reported by travelers and US military personnel.