Immuron Receives FDA Approval for Travelan IND Application

Rhea-AI Summary

Immuron has received FDA approval for its Travelan Investigational New Drug (IND) application aimed at preventing infectious diarrhea caused by enterotoxigenic E. coli (ETEC). The IND is now active, and a clinical trial will commence in the US with plans to recruit 60 healthy volunteers. The trial will evaluate the efficacy of a single 1200 mg dose of Travelan in a controlled environment. Results are expected by year-end 2023. This treatment is significant for travelers and military personnel, given the rising antibiotic resistance affecting traditional treatments.

Positive

• FDA approval for Travelan IND application.
• Active clinical trial to evaluate Travelan's efficacy.
• Target recruitment of 60 healthy volunteers for clinical trial.
• Potential to address antibiotic resistance in infectious diarrhea.

Negative

• None.

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, Dec. 23, 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 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 infection-model 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.

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

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

FAQ

What is the significance of the FDA approval for IMRN?

The FDA approval allows Immuron to proceed with clinical trials evaluating Travelan's efficacy in preventing infectious diarrhea caused by ETEC, which is crucial for travelers and military personnel.

When will the clinical trial for Travelan begin?

Recruitment for the clinical trial is planned to be initiated in the first half of 2023.

What is the expected outcome of the Travelan clinical trial?

The trial aims to report headline results by the end of 2023, evaluating the efficacy of Travelan in a controlled human infection model.

Who will conduct the clinical trial for Travelan?

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