US DoD Naval Medical Research Center Receives FDA Guidance on the clinical development plans for new oral therapeutic
July 20 2020 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the prevention and treatment of gut
mediated pathogens, today is pleased to announce that the Naval
Medical Research Center (NMRC) has received written guidance from
the U.S. Food and Drug administration (FDA) in relation to the
clinical development pathway of a new investigational drug which
the company is developing to treat moderate to severe
campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC)
infections.
The Type B meeting with the FDA discussed the
Chemistry, Manufacturing and Controls including the proposed
release testing specifications of the product as well as the
planned clinical studies evaluating the safety and efficacy of the
product which the company is developing to prevent Campylobacter
and ETEC mediated moderate to severe diarrhea.
The FDA were recently provided a Pre-
Investigational New Drug (IND) package for the new Hyper-immune
therapeutic which specifically targets Campylobacter jejuni capsule
and Enterotoxigenic Escherichia coli (ETEC) colonization factor
antigen 1. Following FDA review the agency provided a written
response to the non-clinical questions posed in the briefing
documentation as well as providing additional guidance and comments
to support the planned IND submission.
“This is an important milestone in the
development of any new drug for therapeutic evaluation. The
information obtained from this review will assist in the
development of the IND application and provides a clear roadmap
forward for conducting the two planned clinical studies next year,”
said Dr. Jerry Kanellos, CEO of Immuron Ltd. “The company is also
please to inform shareholders that the manufacturing program is
proceeding as planned. We have completed the second immunisation
campaign and are on schedule to harvest the Hyper-immune colostrum
in September this year which will be used to manufacture the drug
product that will be used to treat moderate to severe
campylobacteriosis and ETEC infections.”
This release has been authorised by the
directors of Immuron Limited.COMPANY CONTACT:
Dr Jerry Kanellos,
Ph.D.Chief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com
For more information visit:
http://www.immuron.com
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