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- Immuron’s (IMC) lands US Food and Drug Administration (FDA) approval for its investigational new drug application for its Travelan product
- With the approval in hand, IMC can proceed with its clinical trial assessing the safety and efficacy of the drug to prevent infectious diarrhea
- Immuron plans to enrol up to 60 healthy adults in the study, with half to receive a once-daily dose of 1200 milligrams of Travelan and half to receive a placebo
- Recruitment is due to begin in the first half of the new year, with headline results from the trial expected to be reported by the end of 2023
- Immuron shares are up 23.61 per cent and trading at 8.9 cents at 11:56 am AEDT
Immuron’s (IMC) has landed US Food and Drug Administration (FDA) approval for its investigational new drug application for its Travelan product.
With the approval in hand, the company will now proceed with its planned clinical trial assessing the safety and efficacy of the drug to prevent infectious diarrhoea, using a controlled human infection model trial design.
Up to 60 healthy adults will be enrolled in the study, with half to receive a once-daily dose of 1200 milligrams of Travelan and the other half will receive a placebo.
Recruitment is due to begin in the first half of the new year, with headline results from the trial to be reported by the end of 2023.
As announced by the company in October, the trial will be conducted by the Contract Research Organisation Pharmaron CPC at its research facility in Baltimore, Maryland.
Immuron said it would examine a dosing regimen more suited for use by the US military, as troops deployed overseas are among those who report experiencing infectious diarrhoea when visiting developing countries.
The morbidity and associated discomfort stemming from diarrhoea decreases daily performance, affects judgment, decreases morale and declines operational readiness.
As such, a preventative treatment that protects against enteric diseases is a high priority objective for the US military.
Immuron shares were up 23.61 per cent and trading at 8.9 cents at 11:56 am AEDT.
