Immuron's New Drug Collaboration Put on Clinical Hold by FDA

By Connor Hart

Immuron Ltd. on Tuesday said the U.S. Naval Medical Research Center received feedback from the U.S. Food and Drug Administration that its investigational new drug application doesn't contain sufficient information to assess the risk to subjects in its proposed clinical studies.

The investigational new drug has been placed on clinical hold by the FDA, Immuron said.

Immuron, an Australian biopharmaceutical company, previously said that it would be collaborating with the NMRC to develop an oral therapeutic used to treat two common bacterial infections, Campylobacter and Enterotoxigenic Escherichia coli (E. coli), known for causing travelers' diarrhea, nausea, vomiting, stomach cramps and fever.

The development of preventative treatment that protects against endemic diarrheal diseases is a high priority objective for the U.S. military, Immuron said in May.

The NMRC is currently addressing the clinical hold comments and will seek a Type A meeting, set to be scheduled in 30 calendar days from the request, with the FDA to discuss the clinical hold and the necessary protocol amendments, Immuron said Tuesday.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

July 26, 2022 07:08 ET (11:08 GMT)

Immuron (ASX:IMC)
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