Immuron: NMRC's IND Application For Campylobacter ETEC Therapeutic Placed On Clinical Hold By FDA

(RTTNews) - The US Naval Medical Research Center or NMRC has received feedback from the US Food and Drug Administration, indicating that the Investigational New Drug or IND application for a new oral therapeutic targeting Campylobacter and ETEC does not contain sufficient information required under 21 CFR 312.23 to assess the risk to subjects in the proposed clinical studies, Immuron Limited (IMRN, IMC.AX) said in a statement on Tuesday.

Enterotoxigenic Escherichia coli (ETEC) is a type of Escherichia coli and one of the leading bacterial causes of diarrhea in the developing world, as well as the most common cause of travelers' diarrhea.

Immuron, an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, said the IND has been placed on Clinical Hold by the FDA.

The NMRC are currently addressing the clinical hold comments and will seek a Type A meeting with the FDA to discuss the clinical hold and the necessary protocol amendments. The meeting will be scheduled in 30 calendar days from receipt of the NMRC meeting request and background information package.