Immuron to Launch Phase 2 Trial for IMM-529 after FDA Review

Immuron Limited, an Australian biopharmaceutical company, has successfully concluded a pre-IND meeting with the United States Food and Drug Administration (FDA) regarding its investigational drug IMM-529. This meeting provided favorable feedback, supporting continued clinical development plans for IMM-529 aimed at preventing or treating Clostridioides difficile infections (CDI). The company intends to submit an IND application in the first half of 2025, followed by a Phase 2 clinical trial focusing on individuals affected by CDI.

The rising prevalence of antibiotic-resistant bacteria, often referred to as 'superbugs,' has led to an increased use of broad-spectrum antibiotics globally. This widespread use disrupts the balance of gastrointestinal microbiota, making individuals more susceptible to pathogens like Clostridioides difficile. This pathogen, commonly associated with healthcare settings, has been identified as an urgent threat by the Centers for Disease Control and Prevention (CDC) in their 2019 report on antibiotic resistance. Annually, CDI impacts over 400,000 people in the United States, resulting in more than 30,000 deaths. This significant health risk necessitates the development of innovative therapeutics to reduce or replace antibiotics in treating bacterial infections.

Immuron's IMM-529 is being developed as an adjunctive therapy to standard antibiotics for the prevention and treatment of recurrent CDI. The drug contains antibodies targeting Clostridioides difficile, potentially clearing the infection and aiding the restoration of normal gut flora, making it a promising oral preventive treatment for recurrent CDI.

The development of IMM-529 involves collaboration with Dr. Dena Lyras and her team at Monash University in Australia. The team has been working on vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunized to produce hyperimmune bovine colostrum (HBC), which contains antibodies targeting three critical virulence factors of Clostridioides difficile: Toxin B, spores, and surface layer proteins of vegetative cells.

This tri-targeted approach has shown encouraging results in pre-clinical models, demonstrating effectiveness in preventing primary disease, protecting against disease recurrence, and treating primary disease. Notably, IMM-529 antibodies have shown cross-reactivity with multiple human strains of Clostridioides difficile, including hypervirulent strains.

To date, IMM-529 appears to be the only investigational drug that has demonstrated therapeutic potential across all three phases of CDI. According to an opportunity assessment by Lumanity, if IMM-529 proves to be effective, it could be positioned early in the treatment protocol, depending on payer allowances. While the second recurrence of CDI appears to be the initial target, some physicians might consider using IMM-529 earlier for high-risk patients. If positioned at the second recurrence, approximately 31,000 patients could be eligible, potentially rising to about 95,000 if used at the first recurrence. The projected annual revenue for IMM-529, based on market size, payer restrictions, pricing, and competition, is estimated at $93 million. This figure considers a conservative estimate of the target patient population but assumes aggressive use within this group. Greater efficacy could lead to its use in patients after their first recurrence, enlarging the patient pool and increasing revenue. Oral administration of IMM-529 is viewed positively by infectious disease experts, especially compared to current advanced CDI treatments, which are costly and complex.

Immuron remains dedicated to developing and commercializing orally delivered targeted polyclonal antibodies for treating infectious diseases, leveraging its proprietary technology based on polyclonal immunoglobulins derived from engineered hyper-immune bovine colostrum. This technology allows for the creation of highly specific immunoglobulins that remain active in the human gastrointestinal tract, providing a unique platform for developing treatments across various infectious diseases.

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