Shares of Immuron (NASDAQ: IMRN) popped 50% on Friday after the company reported it has received approval from the FDA for its Travelan investigational new drug application.

The company says that a phase 2 clinical trial is planned to evaluate the protective efficacy of a single dose of Travelan in a controlled human infection-model clinical trial design using the enterotoxigenic Escherichia coli (ETEC) strain H10407.

The trial will be conducted by Contract Research Organisation Pharmaron CPC at its FDA-inspected facility in Baltimore.

The company says that the Phase 2 trial will enroll up to 60 healthy adult subjects, who will be randomly assigned to receive either a single dose of 1200 mg of Travelan or a placebo.

Recruitment for the trial is expected to begin in the first half of 2023, with results being reported by the end of the year.

Infectious diarrhea is a common illness among travelers visiting developing countries and among U.S. troops deployed overseas. It can cause decreased daily performance, impaired judgment, decreased morale, and reduced operational readiness.

Antibiotics are currently the first line of treatment for infectious diarrhea, but several enteric pathogens have developed increasing resistance to commonly prescribed antibiotics in recent years.

In addition, travelers' diarrhea is now known to sometimes result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome and various post-infectious autoimmune diseases.

The development of a preventative treatment for enteric diseases is therefore a high priority for the U.S. military.

Shares of Immuron trade on the NASDAQ under the ticker symbol IMRN. For more information visit www.immuron.com.au.