Immuron (ASX:IMC) has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its proprietary oral therapy IMM-529, marking a significant milestone in the company’s effort to combat one of the world’s most persistent and dangerous bacterial infections.
Under the proposed IND, Immuron plans to develop IMM-529 for both the treatment and prevention of recurrent Clostridioides difficile infection (CDI), a life-threatening condition responsible for more than 30,000 deaths annually in the United States. The company expects to begin a Phase 2 clinical trial in the first half of 2026, enrolling patients experiencing either a first or recurrent episode of CDI.
Independent analysis by Lumanity projects that, pending clinical success, IMM-529 could be positioned early in the treatment algorithm, with an estimated annual market potential of around US$400 million. The therapy’s oral delivery has been positively received by infectious disease experts, who see it as a welcome alternative to antibiotic-heavy treatment pathways.
CDI is a growing global health threat, exacerbated by the overuse of antibiotics that disrupt healthy gut flora and increase vulnerability to infection. Current treatment options often rely on further antibiotic use, perpetuating the cycle of relapse. IMM-529 is designed to target three key virulence factors of C. difficile, Toxin B, spores, and surface-layer proteins, enabling it to both treat active infections and prevent recurrence.
Preclinical studies have shown promising results, demonstrating IMM-529’s ability to prevent primary infection (80 per cent), reduce recurrence (67 per cent), and treat active disease (79 per cent), with cross-reactivity against multiple human and animal strains, including hypervirulent variants.
“This IND submission represents a major step forward in Immuron’s infectious disease program,” said Immuron CEO Steven Lydeamore. “IMM-529’s unique mechanism and safety profile position it as a compelling oral therapy addressing a critical unmet need in infectious disease management.”
Immuron is collaborating with Dr Dena Lyras and her team at Monash University, leveraging its proprietary bovine-derived polyclonal antibody platform to create targeted therapies that act directly within the gastrointestinal tract. The same technology underpins Travelan, Immuron’s over-the-counter preventive treatment for travellers’ diarrhoea.