MELBOURNE, Australia, July 26, 2022 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today announced that the US Naval Medical Research Center (NMRC) has received feedback from the US Food and Drug Administration following a review of the 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 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 have 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 being requested for supporting pharmacology/toxicology data. 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.
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Mr Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
For more information visit: http://www.immuron.com
