Immuron Business Update: Letter to Shareholders
22 Juin 2023 - 12:00PM
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 provide the
following business update.
Dear Immuron Limited Shareholders (ASX: IMC; NASDAQ: IMRN),
Immuron is pleased to announce that it has approved proceeding
with IMM-529 cGMP manufacturing and to proceed with FDA pre-IND
submission.
IMM-529 was developed for treatment of
Clostridioides difficile (C. difficile) which is an anaerobic,
spore-forming, gram-positive bacillus typically associated with
gastrointestinal disease. Transmission of C. difficile occurs by
ingestion of spores either through person-to-person contact,
animal-to-person contact or environment-to-person contact. C.
difficile infection (CDI) can cause life-threatening diarrhoea and
is the leading healthcare-related gastrointestinal infection in the
world.1
Lumanity, a leading lifescience consulting
company conducted an opportunity assessment of IMM-529. Infectious
disease experts reacted favourably to the IMM-529 mechanism of
action, and its unique ability to target three elements of the CDI
infection – the spores, vegetative cells, and Toxin B. Base case
yearly revenue in USA for IMM- 529 was estimated at US$92M for the
target patient population (limited to second recurrence and later).
Positioning IMM-529 earlier than second recurrence could lead to
higher uptake. The global CDI market was estimated to increase to
$1.7B by 2026, according to a report by GlobalData.2
Pharmaron have scheduled 96 telehealth screening
interviews since recruitment for the planned Travelan clinical
study was initiated at the end of May 2023 (ASX announcement 30 May
2023). To date 81 potential candidates have been selected for
in-person screening visits which are anticipated to commence on the
28 June 2023 at Pharmaron’s Clinical Research Facility Inpatient
Unit located in Baltimore, Maryland US. The Phase II clinical trial
is designed to evaluate the safety and protective efficacy of
Travelan® compared to a placebo in a controlled human infection
model (CHIM) in up to 60 healthy participants (males or
non-pregnant, non-nursing females), aged 18-50 years.
Thank you for your support.
Steven Lydeamore Chief Executive Officer
- Australian Commission
on Safety and
Quality in
Health
Carehttps://www.safetyandquality.gov.au/publications-and-resources/resource-library/clostridium-difficile-infection-2018-data-snapshot
- GlobalData via
Pharmaceutical
Technologyhttps://www.pharmaceutical-technology.com/research-reports/researchreportreport-clostridium-difficile-infections-market-to-reach-17bn-by-2026-5883581
This release has been authorised by the directors of Immuron
Limited.
Contact Information:Steven
LydeamoreChief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.comhttps://www.immuron.com.au/form/contact-us/
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 inflammatory mediated and infectious
diseases.
For more information visit:
http://www.immuron.com
Immuron (NASDAQ:IMRN)
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