Immuron US DoD Naval Medical Research Center Receives feedback on IND Application for New Campylobacter ETEC Therapeutic

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced that the US Naval Medical Research Center (NMRC) received feedback from the US FDA regarding its Investigational New Drug (IND) application for a new oral therapeutic targeting Campylobacter and ETEC. The FDA identified insufficient information under 21 CFR 312.23 for assessing risks in proposed clinical studies, placing the IND on Clinical Hold. NMRC plans to address these comments and will seek a Type A meeting with the FDA within 30 days to discuss amendments and requirements for moving forward.

Positive

• Previous IND applications by NMRC for similar colostrum-based products were approved without requests for supporting pharmacology/toxicology data.
• NMRC's proactive response to FDA feedback may lead to future approval.

Negative

• The IND is on Clinical Hold, delaying the clinical trials for the oral therapeutic targeting Campylobacter and ETEC.
• FDA required additional information which indicates potential risks in the proposed studies.

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

FAQ

What was the FDA's response to Immuron's IND application for Campylobacter?

The FDA found the IND lacking sufficient information for risk assessment and placed it on Clinical Hold.

What is the significance of the Clinical Hold for IMRN stock?

The Clinical Hold delays clinical trials, which may affect stock performance and investor confidence.

How is Immuron responding to the FDA's concerns about their IND application?

Immuron's NMRC plans to address the FDA comments and will request a Type A meeting to discuss necessary protocol amendments.

When will the NMRC meet with the FDA regarding the Clinical Hold?

The NMRC will schedule a Type A meeting with the FDA within 30 days from their meeting request.