Posted: 10 October 2025
Immuron announced it has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for a Phase II clinical trial of its oral therapy IMM-529 targeting Clostridioides difficile infection (CDI).
The company said C. difficile was “the most common pathogen in healthcare-associated infections and was deemed an urgent threat” in the US Centers for Disease Control and Prevention’s report on antibiotic-resistant threats. CDI affects more than 400,000 people annually in the US and is linked to over 30,000 deaths each year.
IMM-529 is designed as an adjunctive therapy to be used alongside standard-of-care antibiotics for the treatment and prevention of recurrent CDI. Immuron said the Phase II trial was expected to commence by July 2026 and would enrol both first-episode and recurrent CDI patients.
According to the company, IMM-529 has produced “promising results in pre-clinical infection and relapse models,” demonstrating prevention of primary disease (p = 0.0052), protection against recurrence (p < 0.01), and treatment efficacy in primary disease (p < 0.0001). “To our knowledge, IMM-529 is to date the only investigational drug that has shown therapeutic potential in all three phases of the disease,” Immuron said.
The company cited findings from a pre-clinical study titled Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative, published in Scientific Reports (available at http://bit.ly/46TpaaX).
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