By Chris Wack

 

Immuron Ltd. said a new request for $4 million in funding has been considered to be "eligible for award" by the Medical Technology Enterprise Consortium, a U.S. Defense Department funding body.

The company said it is pursuing a regulatory pathway to license Travelan with the U.S. Food and Drug Administration via a biologics license application. The proposed indication is to reduce the risk of contracting travelers' diarrhea caused by bacterial pathogens, it said.

The company said it was recently awarded $3.43 million by MTEC for the development of a Travelan dosing regimen acceptable for use by the U.S. military.

In its new MTEC request for funding, Immuron said it is seeking an additional $4 million to fund the investigational new-drug application, CMC assay development and validation, nonclinical safety studies and stability studies required to support the BLA.

Immuron was formally notified that no government funding is immediately available, it said. However, this application has been deemed "eligible for funding" and will be eligible for award for a period of up to two years, it said.

The company also said that work on the investigational new-drug application to evaluate the efficacy of a single-dose regimen of Travelan in a controlled human infection model clinical study using the enterotoxigenic Escherichia coli strain H10407 is progressing well.

Immuron shares were up 15% to $3.40 in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

April 19, 2022 08:08 ET (12:08 GMT)

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