Immuron Travelers’ Diarrhea Market Update
October 12 2020 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercialising
oral immunotherapeutics for the prevention and treatment of gut
mediated pathogens, today is pleased to provide shareholders and
the market with an update on the planned clinical programs in
Travelers’ Diarrhea (TD).
The Board of Immuron has approved company plans
to recommence the CMC related activities regarding its
investigational drug IMM-124E required to support an
investigational new drug (IND) application to the FDA and the
proposed phase III clinical study in TD.
The company has recently been advised by the
Uniformed Services University (USU) that it has recommenced the
planned clinical trial program to evaluate the efficacy of
non-antibiotic OTC products in Travelers’ Diarrhea and will provide
a purchase order for IMM-124E. USU’s Infectious Diseases Clinical
Research Program (IDCRP), the UK Ministry of Defense and the New
York City Travel Clinic are jointly conducting a randomized
clinical trial to evaluate the efficacy of these nutraceutical
products for TD and inform strategies for Force Health Protection.
The P4TD study is a randomized, double-blind, placebo controlled
multicenter clinical trial designed to evaluate the effectiveness
of 3 commercially available nutraceuticals: a prebiotic (Bimuno®),
a probiotic (Florastor®) and IMM-124E (Travelan®) passive
immunoprophylaxis verses a placebo, for prophylaxis during
deployment or travel to a high-TD risk region. All study
participants (1336 in total) will be randomized to one of the three
active products or placebo (334 per arm).
The company is also pleased to announce that it
has executed a consultancy agreement with Professor Teena Chopra,
Professor of Medicine at Wayne State University School of
Medicine in Detroit, Michigan. Professor Chopra is an
Infectious Disease Epidemiologist with a specific interest in
Clostridioides difficile (C.difficile) infections. Professor
Chopra and her team recently published their research findings on
patients at a hospital associated with the Detroit Medical Center
presenting with both SARS-CoV-2 and C.difficile1. Both infections
can manifest as digestive symptoms and merit screening when
assessing patients with diarrhea. The hospitals associated with the
Detroit Medical Center treated over 600 patients presenting with
COVID-19 during the peak of the pandemic. Professor Chopra and her
team noted that most cases predominantly included pulmonary
symptoms but a small subset of less than 10% of the cases also
included gastrointestinal events. Professor Chopra is building a
registry of the patients presenting with gastrointestinal events to
better understand this cohort and the unique medical challenges
they present, and will be an invaluable resource to access.
__________________________________1
https://doi.org/10.3201/eid2609.202126
“C. difficile infection (CDI) is a challenging
disease, with a recurrence rate of 15%–20% and a mortality rate of
5%. When CDI is present as a co-infection with COVID-19, CDI
therapy can be difficult to monitor if diarrhea persists because of
COVID-19. Our most recent research findings highlight the
importance of judicious use of antibiotics for potential secondary
bacterial infection in patients with COVID-19. Antibiotics are
known to have unintended consequences, such as C. difficile
infection. We recently identified 9 patients in our study who were
elderly, an age group at higher risk for complications from overuse
of antibiotics, such as adverse events, antibiotic resistance, and
concomitant infections like CDI. Immuron’s technology platform is
intriguing because it potentially offers a non-antibiotic solution
to this debilitating disease,” said Professor Chopra.
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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