Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has submitted a response letter to the US FDA regarding a clinical hold on their oral therapeutic targeting Campylobacter and ETEC. This was in response to FDA feedback from its review of the Investigational New Drug (IND) application submitted on July 26, 2022. A virtual meeting held on December 2, 2022, with the FDA, Naval Medical Research Center (NMRC), and Johns Hopkins University discussed the hold and how to address safety concerns. The FDA is expected to provide feedback on the submitted information package within 30 days.

Positive

• Response letter submitted to the FDA indicating progress in addressing safety concerns.
• Collaboration with reputable institutions like Johns Hopkins University and NMRC for product development.

Negative

• Clinical hold placed on trials due to safety concerns noted by the FDA.
• Potential delays in the development timeline for the new oral therapeutic.

MELBOURNE, Australia, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, today announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of the new oral therapeutic under the IND application.

The Sponsor Investigator and Principal Investigator from Johns Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Center (NMRC) and Immuron participated in a virtual meeting with the FDA on the 2 December 2022 to discuss the clinical hold and advise on a path forward to address the safety concerns and supporting data associated with this new product. The FDA provided written guidance to the NMRC following the meeting on the 20 December 2022. NMRC, JHU and Immuron have now addressed the specific concerns of the FDA clinical hold and a response letter has been submitted. The agency will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.

This release has been authorised by the directors of Immuron Limited.

  COMPANY CONTACT:

  Steven Lydeamore
  Chief Executive Officer
  Ph: +61 (0)3 9824 5254
  info@immuron.com

About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN) is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.

For more information visit: http://www.immuron.com

FAQ

What is the current status of Immuron's product under FDA review?

Immuron has submitted a response letter to the FDA regarding the clinical hold on its oral therapeutic targeting Campylobacter and ETEC.

When did Immuron submit its response to the FDA?

The response letter was submitted after feedback received from the FDA regarding the IND application.

What was the reason for the FDA's clinical hold on Immuron's trials?

The FDA placed a clinical hold due to safety concerns associated with the nonclinical data.

How long will it take for the FDA to respond to Immuron's submitted information?

The FDA is expected to provide feedback within 30 calendar days from receipt of the information package.