Immuron seeks pre-IND meeting for IMM-529 with FDA

MELBOURNE, Australia, July 02, 2024 -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical firm, has officially filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for their product IMM-529. CEO Steven Lydeamore expressed enthusiasm over their latest therapeutic advancing towards Phase 2 clinical studies, highlighting the effectiveness of their technology platform.

The rising threat of antibiotic-resistant ‘superbugs' has led to increased use of broad-spectrum antibiotics globally. Unfortunately, this has disrupted the gastrointestinal microbiota, making individuals more susceptible to infections by opportunistic pathogens like Clostridioides difficile (C. diff). Ironically, treating C. diff infections (CDI) also relies heavily on antibiotics, which hampers the recovery of gut flora and increases the likelihood of CDI recurrence. As the most common pathogen in healthcare-associated infections, C. diff is classified as an urgent threat by the CDC's 2019 report on antibiotic resistance. Annually, CDI affects over 400,000 individuals in the U.S., resulting in more than 30,000 deaths. This significant health issue has spurred the need for new treatments to minimize or replace antibiotic use in managing bacterial infections.

Immuron is targeting this need with IMM-529, designed to be used alongside standard antibiotics to prevent or treat recurrent CDI. The antibodies in IMM-529 are aimed at C. diff, potentially helping to clear the infection and expedite the reestablishment of healthy gut flora, offering a promising oral preventive for recurrent CDI.

In collaboration with Dr. Dena Lyras and her team at Monash University, Australia, Immuron is developing vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunized to create hyperimmune bovine colostrum (HBC), which contains antibodies against three crucial C. diff virulence factors. IMM-529 targets Toxin B (TcB), the spores, and the surface layer proteins of the vegetative cells.

This comprehensive approach has shown promising results in pre-clinical models of infection and relapse, including an 80% prevention rate of primary disease, a 67% protection rate against disease recurrence, and a 78.6% treatment success rate for primary disease. Notably, IMM-529 antibodies cross-react with various human strains of C. diff, including hypervirulent strains. To date, IMM-529 is the only investigational drug demonstrating potential across all three disease phases.

Lumanity's opportunity assessment suggests that if IMM-529 proves effective, it could be positioned early in treatment protocols, depending on payer policies. It's estimated that around 31,000 patients would be eligible if IMM-529 is used after the second recurrence of CDI. This number could rise to approximately 95,000 if used after the first recurrence. Based on market size, payer restrictions, pricing, and competition, IMM-529 could generate an annual revenue of about $93 million. This figure considers a conservative target population (limited to second recurrence and beyond) but assumes aggressive use (75%) within that group. Higher efficacy could expand its use to first recurrence patients, potentially adding 9,500 patients and $48 million in annual revenue. Experts view the oral administration of IMM-529 positively, especially as current advanced CDI treatments are expensive and complex to administer.

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