Immuron (NASDAQ: IMRN), plans IND submission for CDI treatment in 2025
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company, has announced plans to submit an investigational new drug (IND) application for IMM-529, aimed at preventing or treating Clostridioides difficile infection (CDI). This follows positive feedback from the U.S. Food and Drug Administration (FDA) on its pre-IND meeting.
IMM-529 is designed as an adjunctive therapy to be used alongside standard antibiotics for the prevention and treatment of recurrent CDI. The therapy utilizes antibodies derived from bovine colostrum, targeting three key virulence components of C. diff: Toxin B, spores, and surface layer proteins. Early clinical trial data supports the continued development of IMM-529, with pre-clinical studies showing the potential to prevent primary disease, protect against disease recurrence, and treat primary disease.
The global rise in antibiotic-resistant ‘superbugs’ has led to an increase in the use of broad-spectrum antibiotics, which can disturb the gut microbiota and heighten the risk of opportunistic infections like CDI. CDI is recognized as an urgent threat by the CDC and is the most common pathogen in healthcare-associated infections in the United States, affecting over 400,000 people and contributing to more than 30,000 deaths annually.
Immuron’s collaboration with Dr. Dena Lyras and her team at Monash University has been instrumental in developing IMM-529. The company’s proprietary technology involves immunizing dairy cows to produce hyperimmune bovine colostrum containing targeted antibodies.
An assessment by Lumanity suggests that IMM-529, if efficacious, could be positioned early in the CDI treatment algorithm. Estimates project a base case yearly revenue for IMM-529 at US$93M, assuming the drug is used predominantly after the second recurrence of CDI. The ease of oral dosing is seen as a benefit by infectious disease experts, especially when compared to more complex treatments like fecal microbiota transplantation.
Immuron plans to file the IND application for IMM-529 in the first half of 2025, with a subsequent Phase 2 trial for individuals with CDI. This news is based on a press release statement issued by Immuron Limited.