Immuron (ASX:IMC) has announced that the US Naval Medical Research Center (NMRC) has received feedback from the US FDA following a review of the Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC.
The company said the regulator has specified that the IND does not contain sufficient information required under 21 CFR 312.23 to assess the risk to subjects in the proposed clinical studies. The IND has been 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.
Immuron said the NMRC has previously filed and had IND applications approved by the FDA on similar colostrum-based products without being requested for supporting pharmacology/toxicology data. It added that the NMRC is 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.