Immuron's IND Application For Bacterial Infection Candidate Placed On Clinical Hold

  • The U.S. Naval Medical Research Center (NMRC) has received FDA feedback related to Immuron Limited's IMRN Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC.
  •  The agency has specified that the IND does not contain sufficient information 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. 
  • The NMRC has previously filed and had IND applications approved by the FDA on similar colostrum-based products without requesting supporting pharmacology/toxicology data. 
  • The NMRC is 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. 
  • MMRC was preparing to commence the first of the two planned clinical trials in the U.S. 
  • The safety and protective efficacy of the product will be tested in two clinical trials, with one trial focusing on the ability of the product to protect volunteers against ETEC infections and the second trial focusing on moderate to severe campylobacteriosis. 
  • A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the studies.
  • Price Action: IMRN shares closed at $2.45 on Monday.
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