Immuron Limited announced that IMM-529, a first-in-class oral therapeutic, successfully demonstrated prevention of Clostridium difficile (C. difficile) infection recurrence in over 77.8% of infected mice. The mouse model developed by Associate Professor Dena Lyras and her team at Monash University was designed to evaluate the effectiveness of IMM-529 when used in conjunction with standard of care antibiotic treatment. Combination therapy with IMM-529 and vancomycin significantly reduced disease recurrence and mortality to 22.2% compared to 88.9% mortality in the control, vancomycin only group.

The results were statistically significant. Current therapies are based on antibiotics that have limited efficacy and cause an imbalance in the microbiome that may result in the recurrence of the disease. Several companies are pursuing new therapeutics to combat C. difficile, however Immuron's program is unique as it is not only targets toxin B but also the spores and the vegetative cells which are thought to be the primary cause of the recurrences that make C. difficile so difficult to treat.

IMM-529 is a biologic which is intended to prevent and treat C. difficile infections and does not destroy the microbiome like antibiotic treatments, allowing the microbiome to return to a healthy state. The antibodies in IMM-529 have been demonstrated to be cross-reactive with a variety of human and animal C. difficile isolates and to their associated Toxin B, vegetative cell and spore components. The antibodies in IMM-529 have also been shown to neutralise Toxin B from a historical C. difficile strain (630) and from a hypervirulent (HV) strain which caused the recent worldwide outbreaks.