Immuron: FDA Removes Clinical Hold on New Campylobacter ETEC Therapeutic IND Application
May 08 2023 - 5:48AM
Dow Jones News
By Chris Wack
Immuron Ltd. said Monday that the U.S. Naval Medical Research
Center has received approval from the U.S. Food and Drug
Administration to proceed with the clinical evaluation of a new
oral therapeutic targeting Campylobacter and Enterotoxigenic
Escherichia coli, developed in collaboration with Immuron.
The biopharmaceutical company said the FDA has removed a
clinical hold on the Investigational New Drug application allowing
the NMRC to proceed with its plans to evaluate the efficacy of the
hyperimmune product to prevent infectious diarrhea caused by
Campylobacter and ETEC which is now active.
The safety and protective efficacy of the product will be tested
using two controlled human infection-model clinical trials, with
one trial focusing on the ability of the hyperimmune product to
protect volunteers against ETEC infections, and the second trial
focusing on moderate to severe campylobacteriosis.
The first clinical study will be conducted at the Johns Hopkins
University Center for Immunization Research Inpatient Unit, and
will include 30 healthy participants, aged 18-50 years.
Immuron shares were up 44% to $2.70 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
May 08, 2023 06:33 ET (10:33 GMT)
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