Immuron Limited received FDA approval for Travelan IND Application

Dec 23, 2022

Immuron Limited (ASX: IMC) announced that it had received approval from the US Food and Drug Administration to continue with the clinical assessment of Travelan. The Investigational New Drug (IND) application assesses the effectiveness of a single dose of Travelan to avert infectious diarrhea reported by travelers visiting developing countries and among US troops deployed overseas.

As a result of this approval, it will continue with the scheduled clinical trial in the United States. The safety and defensive efficiency of Travelan will be tested using a controlled human infection model clinical trial design. The company also highlighted that it is the sponsor of the IND, and the clinical study will be directed by the Contract Research Organisation Pharmaron CPC, Inc at its FDA-examined clinical research facility situated in Baltimore, Maryland, in the USA.

 

 

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