Immuron Business Update: Letter to Shareholders

June 22, 2023 at 06:00 AM EDT

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 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 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
info@immuron.com
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