Immuron Announces FDA Removed Clinical Hold on New Campylobacter ETEC Therapeutic Paves way for Clinical Trial Initiation
May 08 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, is pleased to announce that the
US Naval Medical Research Center (NMRC) has received approval from
the US Food and Drug Administration (FDA) to proceed with the
clinical evaluation of a new oral therapeutic targeting
Campylobacter and Enterotoxigenic Escherichia coli (ETEC) developed
in collaboration with Immuron. The FDA has removed a clinical hold
on the Investigational New Drug (IND) application allowing the NMRC
to proceed with its plans to evaluate the efficacy of the
hyperimmune product to prevent infectious diarrhoea caused by
Campylobacter and ETEC which is now active.
The safety and protective efficacy of the
product will be tested utilising 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 randomized,
placebo-controlled trials and randomly assigned to either Cohort 1
ETEC or Cohort 2 C. jejuni controlled human infection models
(https://www.who.int/publications/i/item/9789240037816).
The first clinical study will be conducted at
the Johns Hopkins University (JHU) Center for Immunization Research
(CIR) Inpatient Unit, located at the Johns Hopkins Bayview Medical
Campus. The study population will include 30 healthy participants
(males or non-pregnant, non-nursing females), aged 18-50 years.
Commencement is subject to ethics approval from the Institutional
Review Board.
Infectious diarrhoea is the most common illness
reported by travellers visiting developing countries and among US
troops deployed overseas. The morbidity and associated discomfort
stemming from diarrhoea decreases daily performance, affects
judgment, decreases morale and declines operational readiness. The
first line of treatment for infectious diarrhoea is the
prescription of antibiotics. Unfortunately, in the last decade,
several enteric pathogens have had an increasing resistance to
commonly prescribed antibiotics. In addition, traveller’s diarrhoea
is now recognised by the medical community to result in
post-infectious sequelae, including post-infectious Irritable Bowel
Syndrome and several post-infectious autoimmune diseases. A
preventative treatment that protects against enteric diseases is a
high priority objective for the US Military.
This release has been authorised by the
directors of Immuron Limited.
COMPANY
CONTACT:Steven LydeamoreChief Executive
OfficerPh: +61 (0)3 9824
5254steve@immuron.com |
About Travelan®
Travelan® is an orally administered passive
immunotherapy that prophylactically reduces the likelihood of
contracting traveller’s diarrhoea, a digestive tract disorder that
is commonly caused by pathogenic bacteria and the toxins they
produce. Travelan® is a highly purified tabletised preparation of
hyperimmune bovine antibodies and other factors, which when taken
with meals bind to diarrhoea-causing bacteria and prevent
colonisation and the pathology associated with traveller’s
diarrhoea. In Australia, Travelan® is a listed medicine on the
Australian Register for Therapeutic Goods (AUST L 106709) and is
indicated to reduce the risk of Traveller’s Diarrhoea, reduce the
risk of minor gastrointestinal disorders and is antimicrobial. In
Canada, Travelan® is a licensed natural health product (NPN
80046016) and is indicated to reduce the risk of Traveller’s
Diarrhoea. In the U.S., Travelan® is sold as a dietary supplement
for digestive tract protection.
About Traveller’s Diarrhoea
Traveller’s Diarrhoea is a gastrointestinal
infection with symptoms that include loose, watery (and
occasionally bloody) stools, abdominal cramping, bloating, and
fever, Enteropathogenic bacteria are responsible for most cases,
with enterotoxigenic Escherichia coli (ETEC) playing a dominant
causative role. Campylobacter spp. are also responsible for a
significant proportion of cases. The more serious infections with
Salmonella spp. the bacillary dysentery organisms belonging to
Shigella spp. and Vibrio spp. (the causative agent of cholera) are
often confused with Traveller’s Diarrhoea as they may be contracted
while travelling and initial symptoms are often
indistinguishable.
About ImmuronImmuron Limited
(ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical
company focused on developing and commercialising orally delivered
targeted polyclonal antibodies for the treatment of infectious
diseases.
For more information visit:
http://www.immuron.com
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