Immuron submitts IND application to FDA for clinical development of IMM-529

Immuron (IMRN) announced that it has submitted an Investigational New Drug, or IND, application to the FDA for clinical development of IMM-529. Under this new IND, Immuron is proposing the development of IMM-529 for treatment of Clostridioides difficile, or C. diff, infection, or CDI, and prevention of recurrent CDI, or rCDI. The Company plans to initiate a Phase 2 clinical trial for IMM-529 in individuals with Clostridioides difficile infection, or CDI, during the first half of 2026. Independent Market analysis conducted by Lumanity suggests that, pending demonstration of efficacy, IMM-529 could be positioned at the earliest point in the treatment algorithm permitted by payer guidelines. The Phase 2 clinical trial is expected to enroll both first episode and recurrent CDI patients. The estimated eligible population of patients would be approximately 98,000 individuals if IMM-529 is introduced as a treatment at the first recurrence stage. 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 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. To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the treatment of CDI and prevention recurrent CDI. IMM-529 has been designed with antibodies that target the key essential virulence components of C. diff, with the potential to accelerate the clearance of CDI infection and support rapid restoration of healthy gut microbiota. This novel 3-target approach has yielded promising results in pre-clinical infection and relapse models, including Prevention of primary disease; Protection of disease recurrence and Treatment of primary disease. Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human and animal strains of C. diff including hypervirulent strains.