Immuron's New Drug Collaboration Put on Clinical Hold by FDA
July 26 2022 - 7:23AM
Dow Jones News
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)
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