Immuron US DoD Naval Medical Research Center Submits IND Application for New Campylobacter ETEC Therapeutic
May 11 2022 - 6:00AM
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 is pleased to announce that the US Naval
Medical Research Center (NMRC) has submitted an Investigational New
Drug (IND) application to the US Food and Drug Administration for a
new oral therapeutic targeting Campylobacter and ETEC developed in
collaboration with Immuron.
NMRC is preparing to commence the first of two
planned clinical trials in the United States following approval of
the application. The safety and protective efficacy of the product
will be tested utilizing two controlled human infection-model
clinical trials, with one trial focusing on the ability of the
hyperimmune product to protect volunteers against ETEC infections,
and the second trial focusing on moderate to severe
campylobacteriosis. A total of 60 volunteers divided into two
inpatient cohorts will be enrolled in the studies and randomly
assigned to either Cohort 1 ETEC or Cohort 2 C. jejuni controlled
human infection models.
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and amongst US
troops deployed overseas. The morbidity and associated discomfort
stemming from diarrhea decreases daily performance, affects
judgment, decreases morale, and declines operational readiness. The
first line of treatment for infectious diarrhea is the prescription
of antibiotics. Unfortunately, in the last decade, several enteric
pathogens have an increasing resistance to commonly prescribed
antibiotics. In addition, travelers' diarrhea is now recognized by
the medical community to result in post-infectious sequelae,
including post-infectious irritable bowel syndrome and several
post-infectious autoimmune diseases. The development of an oral
immunotherapy preventative treatment that protects against endemic
diarrheal diseases, is a high priority objective for the US
Military.
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 |
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For more information visit:
http://www.immuron.com
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