Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic
January 25 2023 - 6:00AM
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 ImmuronImmuron 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
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