Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has received “favourable feedback” from the United States Food and Drug Administration (FDA) in support of the development of its IMM-529 product to prevent or treat Clostridioides difficile infection (CDI).
After completing a pre-IND (investigational new drug) meeting with the FDA, Immuron received feedback on the pre-IND information package that supports the clinical development of IMM-529 to specifically prevent or treat CDI.
Addressing an unmet need
The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff).
Paradoxically, treatment of CDI also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI.
C. diff is currently the most common pathogen in healthcare associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States.
CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.
To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI.
It is Immuron’s belief that IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI.
Investigational new drug (IND) application
Following the FDA’s guidance and feedback, Immuron plans to file an investigational new drug (IND) application during the first half of 2025 for IMM-529 to prevent or treat CDI, followed by a Phase 2 trial of IMM-529 in individuals with CDI.
Immuron is collaborating with Dr Dena Lyras and her team at Monash University, Australia, to develop vaccines to produce bovine colostrum-derived antibodies.
Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components — Toxin B (TcB), the spores, and the surface layer proteins of the vegetative cells.
This three-target approach has yielded promising results in pre-clinical infection and relapse models, and according to IMC, IMM-529 is the only investigational drug that has shown therapeutic potential in all three phases of the disease.
IMM-529 revenue projected at US$93 million
An opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. It says use of IMM-529 for a second recurrence is most likely, but some doctors who treat aggressively or see a patient as being especially high-risk may turn to IMM-529 even earlier.
Immuron estimates that up to 31,000 patients would be eligible if IMM-529 is positioned at the second recurrence, and up to 95,000 patients would be eligible if positioned at the first recurrence.
Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue for IMM-529 is projected at US$93 million.
The company says that the estimate of US$93 million represents a conservative view of the target patient population (limited to second recurrence and later by trial design and payer coverage) but likely aggressive use (75%) within that target patient population.
However, greater efficacy may lead to greater use in patients after their first recurrence, increasing the size of the patient population. Even capturing as few as 10% of first recurrence patients adds up to 9,500 patients to the treated pool, which could add up to US$48 million in yearly revenue.
Read more on Proactive Investors AU
