• Immuron submits Investigational new drug (IND) application to FDA for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI)
• Previous clinical trial data on IMM-529 provides support for continued development
• Phase 2 clinical trial for IMM-529 in individuals with CDI planned for first half of 2026

Immuron Limited has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for the clinical development of IMM-529. Under this new IND, Immuron is proposing the development of IMM-529 for the treatment of Clostridioides difficile (C. diff) infection (CDI) and prevention of recurrent CDI (rCDI). The company plans to initiate a Phase 2 clinical trial for IMM-529 in individuals with Clostridioides difficile infection (CDI) during the first half of 2026. Independent market analysis suggests that, pending demonstration of efficacy, IMM-529 could be positioned at the earliest point in the treatment algorithm permitted by payer guidelines. The Phase 2 clinical trial is expected to enroll both first episode and recurrent CDI patients. The estimated eligible population of patients would be approximately 98,000 individuals if IMM-529 is introduced as a treatment at the first recurrence stage. Considering market size, anticipated payer dynamics, competitive landscape, and pricing assumptions, the base case annual revenue potential for IMM-529 is projected at approximately US$400M. Additionally, the oral administration route has been positively received by infectious disease specialists, reinforcing IMM-529's clinical and commercial appeal. IMM-529 has been designed with antibodies that target the key essential virulence components of C. diff, with the potential to accelerate the clearance of CDI infection and support rapid restoration of healthy gut microbiota. This mechanism of action positions IMM-529 as a compelling oral therapeutic drug candidate for the treatment of CDI and prevention of disease recurrent CDI, addressing a critical unmet need in infectious disease management.