FDA Lifts Clinical Hold From Immuron's New Campylobacter ETEC Therapeutic Study

Immuron Limited IMRN has announced that the U.S. Naval Medical Research Center (NMRC) has received FDA approval to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed in collaboration with Immuron. 

The FDA has removed a clinical hold on the Investigational New Drug (IND) 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 utilizing 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. 

Sixty volunteers will be divided into two inpatient cohorts.

The first clinical study will be conducted at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit. 

The study population will include 30 healthy participants.

The FDA placed the clinical hold in July 2022. The agency specified that the IND does not contain sufficient information required to assess the risk to subjects in the proposed clinical studies.

Price Action: IMRN shares are up 33.2% at $2.49 on the last check Monday.