Immuron Gets FDA Approval to Proceed With Travelan Evaluation
December 23 2022 - 6:50AM
Dow Jones News
By Chris Wack
Immuron Ltd. said Friday that it has received approval from the
U.S. Food and Drug Administration to proceed with the clinical
evaluation of Travelan.
The company said the Investigational New Drug application to
evaluate the efficacy of a single dose of Travelan to prevent
infectious diarrhea caused by enterotoxigenic Escherichia coli
strain H10407 is now active.
As a result of this approval, the company will proceed with its
planned clinical trial in the U.S. The safety and protective
efficacy of Travelan will be tested using 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 Organization Pharmaron CPC
Inc. at its FDA inspected clinical research facility located in
Baltimore.
The Phase II clinical trial will evaluate the efficacy of a
single dose regimen of Travelan in a controlled human infection
model using the enterotoxigenic Escherichia coli strain H10407.
Recruitment is planned to be initiated in the first half of 2023,
with headline results from the clinical trial expected to be
reported by year end 2023.
Immuron shares were up 55% to $2.48 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 23, 2022 06:35 ET (11:35 GMT)
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