Immuron Advances IMM-529 Development Following FDA Feedback
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Immuron Sets Course for Phase 2 Trial of IMM-529
Key Highlights
- Immuron wraps up key pre-IND meeting with FDA regarding IMM-529 aimed at treating Clostridioides difficile infection (CDI).
- Previous clinical trials underscore the need for continued progress with IMM-529.
- Plans to submit IND application for IMM-529 in the first half of 2025.
Melbourne, Australia - Immuron Limited (ASX: IMC; NASDAQ: IMRN), a dynamic biopharmaceutical firm with a global reach, is excited to share that it has received positive feedback from the United States Food and Drug Administration (FDA) regarding its pre-investigational new drug (pre-IND) package aimed at supporting the development of IMM-529.
In light of the FDA's guidance, Immuron is now gearing up to submit an IND application for IMM-529, which is designed to prevent or treat Clostridioides difficile infections (CDI), anticipated in the first half of 2025. Following this submission, the company plans to initiate a Phase 2 trial for individuals impacted by CDI.
The rise of antibiotic-resistant infections has surged globally, leading to a heavier reliance on broad-spectrum antibiotics. This trend inadvertently disrupts the gut microbiome, making individuals more susceptible to opportunistic pathogens, including C. diff. Ironically, the treatment regimen for CDI often involves antibiotics, hindering the recovery of gut flora and increasing the risk of recurrence. C. diff currently stands as a major threat in healthcare settings, with annual CDI cases exceeding 400,000 in the U.S., resulting in over 30,000 deaths, underscoring the urgent need for innovative treatment options.
To confront this challenge, Immuron is advancing IMM-529 as a supplementary therapy to be combined with conventional antibiotics for both the prevention and treatment of recurrent CDI. The antibodies present in IMM-529 are designed to target C. diff effectively, assisting in the elimination of the infection while promoting the prompt restoration of a healthy gut microbiome, making it a promising oral solution for recurrent CDI cases.
Collaborating with Dr. Dena Lyras and her research team at Monash University, Immuron is also focused on developing vaccines aimed at generating bovine colostrum-derived antibodies. By immunizing dairy cows, they produce hyperimmune bovine colostrum (HBC), rich in antibodies directed against crucial C. diff virulence factors. Specifically, IMM-529 targets Toxin B (TcB), as well as spores and surface proteins from the vegetative cells.
This innovative triple-target strategy has yielded remarkable outcomes in pre-clinical models, showcasing an impressive (1) prevention of primary disease (80%, P = 0.0052); (2) reduction in recurrence rates (67%, P < 0.01); and (3) effective treatment of primary disease (78.6%, P < 0.0001; TcB HBC). Notably, the antibodies in IMM-529 exhibit cross-reactivity with numerous human C. diff strains, including hypervirulent types.
To date, IMM-529 stands out as the only investigational therapy demonstrating therapeutic potential across all three phases of CDI. Insights from opportunity assessments indicate that if IMM-529 proves effective, it could be integrated early into treatment protocols as insurance providers deem appropriate. Options for patients undergoing treatment after one course each of fidaxomicin and vancomycin suggest that approximately 31,000 patients would qualify for the therapy, while those dealing with their first recurrence could push the eligible patient count to 95,000. Current market evaluations estimate annual revenue potential for IMM-529 could reach around USD 93 million, based on conservative assumptions regarding patient eligibility and treatment uptake within the defined patient population post-second recurrence.
Experts in infectious diseases consider the oral administration of IMM-529 a significant advantage, especially when juxtaposed against existing treatment modalities like bezlotoxumab and fecal microbiota transplants, which can be both costly and complicated.
For any inquiries, please contact:
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
steve@immuron.com
About Immuron
Immuron Limited (ASX: IMC; NASDAQ: IMRN) is committed to developing and commercializing targeted oral therapies focusing on polyclonal antibodies for infectious disease treatment.
Immuron's Innovative Technology
Immuron specializes in producing polyclonal immunoglobulins (IgG) derived from hyper-immune bovine colostrum. This technology enables the creation of highly specific immunoglobulins targeting various enteric pathogens, with the distinct advantage of being orally active. The bovine IgG withstands stomach acid and digestive breakdown, maintaining its effectiveness within the human digestive system to provide benefits directly to the gut microbiota.
Frequently Asked Questions
What is IMM-529 designed for?
IMM-529 aims to prevent and treat Clostridioides difficile infections (CDI), which pose a significant health risk due to antibiotic resistance.
Who is Immuron collaborating with?
Immuron is working alongside Dr. Dena Lyras and her team at Monash University to develop the necessary antibodies for IMM-529.
What makes IMM-529 unique?
It is the only investigational drug that has shown therapeutic potential in all three phases of C. diff disease treatment.
How does IMM-529 benefit gut health?
IMM-529 helps clear C. diff infections, promoting a faster re-establishment of healthy gut flora.
What revenue potential does IMM-529 have?
Projected annual revenue for IMM-529 could reach approximately USD 93 million if successful in the market.
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