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Immuron (ASX:IMC) takes steps towards FDA approval for stomach bug treatment
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  • Immuron (IMC) is set to start clinical trials of its candidate drug, IMM124E, in collaboration with the U.S.-based Uniformed Services University
  • The drug, trademarked as Travelan, will be tested against other therapies in a randomised, double-blind, placebo controlled multi-centre clinical study
  • A positive outcome will support an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) and the proposed phase 3 clinical study in travellers'stomach flu
  • The company has also executed a consultancy agreement with Professor Teena Chopra of Wayne State University School of Medicine, in Detroit, Michigan
  • Immuron closed Monday's session 14 per cent higher at 32.5 cents

Biopharma company Immuron (IMC) is set to start clinical trials of its candidate drug, IMM124E, in collaboration with the U.S.-based Uniformed Services University.

The drug, trademarked as Travelan, will be tested in a randomised, double-blind, placebo controlled multi-centre clinical study to support a potential phase 3 trial.

The study

Immuron has recently been advised by the Uniformed Services University (USU) that it has recommenced the planned clinical trial program to evaluate the efficacy of non-antibiotic over-the-counter products for Travelers’ Diarrhoea (TD).

The USU study will test Travelan and two other drugs against a placebo to evaluate their effectiveness in preventing TD.

USU’s Infectious Diseases Clinical Research Program, the UK Ministry of Defence and the New York City Travel Clinic are jointly conducting the randomised clinical trials.

Immuron is hoping Travelan proves effective as a non-antibiotic prophylactic against TD. A positive outcome will support an investigational new drug (IND)
application to the U.S. Food and Drug Administration (FDA) and the proposed phase 3 clinical study in TD.

The company has also executed a consultancy agreement with Professor Teena Chopra of Wayne State University School of Medicine, in Detroit, Michigan.

Professor Chopra is an infectious disease epidemiologist with a specific interest in Clostridiodes difficle (C.difficle) infections, which cause the stomach flu and often require non-antibiotic remedies in vulnerable populations such as the elderly.

The next steps

Professor Chopra is working on a small subset of COVID-19 patients which present with gastrointestinal symptoms.

The use of non-antibiotic treatments in this patient cohort is of particular importance, given the fragility of the immune systems of vulnerable patients, including the elderly and people with comorbidities.

Professor Chopra says a drug like Travelan could help in the treatment of such vulnerable groups, both with COVID-19 and TD.

"Antibiotics are known to have unintended consequences, such as C. difficile infection," Professor Chopra said.

"We recently identified nine patients in our study who were elderly, an age group at higher risk for complications from overuse of antibiotics, such as adverse events, antibiotic resistance, and concomitant infections like CDI," she added.

"Immuron’s technology platform is intriguing because it potentially offers a non-antibiotic solution to this debilitating disease."

Immuron will continue working towards FDA approval for Travelan as it gathers more clinical data.

Immuron closed Monday's session 14 per cent higher at 32.5 cents.

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