Highlights:
-
Immuron Board approves
IMM-529 cGMP manufacturing
and to
proceed with FDA pre-IND
submission -
Recruitment and screening update for Travelan® Controlled Human Infection Model (CHIM)
Clinical Trial
MELBOURNE, Australia, June 22, 2023 (GLOBE NEWSWIRE) — 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 Clostridioidesdifficile (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
Care
https://www.safetyandquality.gov.au/publications-and-resources/resource-library/clostridium-difficile-infection-2018-data-snapshot -
GlobalData
via
Pharmaceutical
Technology
https://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 Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
[email protected]
https://www.immuron.com.au/form/contact-us/
About
Immuron
Immuron 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
