Immuron Receives A$6.2 Million Award from U.S. DoD to Clinically Evaluate a Military Strength Dosing Regimen for Travelan
January 12 2022 - 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, is pleased to announce the funding of a new
research agreement with the U.S Department of Defense.
The focus of this new agreement, entitled
“Biologics License Application (BLA) of a therapeutic Bovine
Immunoglobulin supplement targeting Travelers’ Diarrhea caused by
Enterotoxigenic Escherichia Coli (ETEC)”, is aimed at testing and
confirming the efficacy of a single larger dose regimen of
Travelan® in a controlled human infection model (CHIM) clinical
study using the enterotoxigenic Escherichia coli (ETEC) strain
H10407. This single larger dosing regime is potentially more
amenable for use in military populations. Up to 60 volunteers will
be enrolled in the clinical study and will be randomly assigned to
receive either a once-daily dose of 1200 mg of Travelan® or
placebo. This study will occur across two cohorts (n=15 Travelan®
subjects and n=15 placebo subjects per cohort), as the inpatient
unit can accommodate up to 30 study participants at a time. Results
of the proposed clinical study will also inform on dosing in the
pivotal Phase 3 registration trials for BLA licensure. A project
kickoff meeting for this award has been scheduled for the end of
January with the U.S Government sponsors.
The proposed development program is based on the
past commercial and clinical trial experience with Travelan®. Two
company sponsored clinical studies have demonstrated that Travelan®
conferred 84% to over 90% protective efficacy against moderate to
severe diarrhea upon challenge with ETEC in comparison to a
placebo. These clinical studies were performed using two different
doses of Travelan® (200 mg and 400 mg), administered three times a
day. Ongoing discussions with Army and Navy leadership have
highlighted that such a regimen is cumbersome for military
personnel deployed in austere environments and military field
studies have shown that compliance is low with products dosed more
than once per day.
“This new project expands our clinical
development program and represents the first of several significant
clinical trials which the Company expects to undertake with the US
Military in 2022. The NMRC also plans to clinically evaluate the
protective efficacy of our new oral therapeutic targeting
Campylobacter and ETEC this year in two controlled human
infection-model clinical trials, with one trial focusing on the
ability of the hyperimmune product to protect volunteers against
moderate to severe campylobacteriosis, and the second trial
focusing on ETEC infections,” said Dr. Jerry Kanellos, CEO
of Immuron. “The new funding is testament to the value
proposition our hyperimmune bovine polyclonal colostrum technology
offers to benefit the US Military as well as the civilian
international travelling population.”
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and among US
troops deployed overseas. The morbidity and associated discomfort
stemming from diarrhea decreases daily performance, affects
judgment, decreases morale, and lowers 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. 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:Dr Jerry
Kanellos, Ph.D.Chief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com |
US INVESTOR
CONTACTDave Gentry, CEORedChip Companies
Inc.+1-407-491-4498dave@redchip.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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