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Immuron has filed a pre‑Investigational New Drug (pre‑IND) application with the U.S. Food and Drug Administration for IMM‑529, an adjunctive oral therapy designed to prevent and treat recurrent Clostridioides difficile infection (CDI). CDI affects over 400,000 people annually in the U.S., leading to more than 30,000 deaths and is recognised as an urgent public health threat in the CDC’s antibiotic resistance report. IMM‑529 represents a unique tri‑target mechanism, addressing Toxin B, spores, and vegetative surface proteins of C. difficile, using hyperimmune bovine colostrum–derived antibodies, developed in collaboration with Monash University. Pre‑clinical models demonstrate high efficacy across all disease phases—80% prevention of primary infection, 67% protection against recurrence, and 78.6% treatment success—and cross-reactivity with hypervirulent strains. A Lumanity market assessment projects a base‑case annual U.S. revenue of USD $93 million, with higher upside potential if IMM‑529 is used earlier in the treatment paradigm.

MarketOpen: Immuron files FDA application for deadly C. diff infection fight