Immuron: FDA Removes Clinical Hold on New Campylobacter ETEC Therapeutic IND Application

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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