• Immuron receives FDA approval for IMM-529 Investigational New Drug (IND) application
• Phase 2 clinical trial for IMM-529 to treat Clostridioides difficile infection (CDI) to commence in 2026
• IMM-529 targets 3 key C. diff virulence components, showing promise in pre-clinical studies

Immuron Limited announced that the United States Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for IMM-529, and the Phase 2 clinical trial may proceed. The Phase 2 trial will be a randomized, double-blind, placebo-controlled study of IMM-529 in combination with Standard of Care (SOC) for the treatment of CDI in subjects with first episode CDI or recurrent CDI. Up to 60 subjects will be enrolled across multiple sites in Australia. The primary objective will be to evaluate the safety and tolerability of IMM-529 with SOC, while efficacy will be assessed by measuring mortality rate, disease symptoms, and recurrence rate. Immuron's IMM-529 is a unique 3-target approach that has shown promise in pre-clinical studies, including prevention of primary disease, protection against disease recurrence, and treatment of primary disease. Importantly, IMM-529 antibodies cross-react with many different human strains of C. diff, including hypervirulent strains. Immuron believes that if IMM-529 is found to be efficacious, it will be positioned early in the treatment algorithm for CDI, with a potential market size of up to ~98,000 patients in the US alone.

Based on the estimated market size, anticipated payer restrictions, pricing, and competition, Immuron projects a base case yearly revenue for IMM-529 of US$400M.