IMRN - Immuron says proposed trials of antibacterial drug put on clinical hold by FDA

• The U.S. Food and Drug Administration placed a clinical hold on the start of trials of an oral antibacterial drug, noting insufficient information in the investigational new drug  (IND) application.
• Australia-based Immuron ( NASDAQ: IMRN ) said that the US Naval Medical Research Center (NMRC) has received feedback from the FDA following a review of the IND application for a new oral therapeutic targeting Campylobacter and ETEC.
• Campylobacter is an infection causing diarrhea due to the Campylobacter bacteria. Meanwhile, Enterotoxigenic Escherichia coli (E. coli), or ETEC , is also an important cause of bacterial diarrheal illness, as per the CDC.
• The FDA said that the IND does not contain sufficient information required to assess the risk to patients in the proposed clinical studies, Immuron said in a July 26 press release.
• Immuron added that the IND was placed on clinical hold until the FDA has received and reviewed a response from the NMRC justifying dosing, safety monitoring and a risk mitigation plan.
• The company noted that NMRC is addressing the clinical hold comments and will seek a Type A meeting with the FDA to discuss the hold and necessary protocol amendments.

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