Immuron (ASX:IMC) has provided an update on its U.S. clinical programs for Travelan and IMM-529, confirming progress in its regulatory engagement with the U.S. Food and Drug Administration (FDA) and outlining next steps following minor protocol updates.
The company has received formal acknowledgement from the Center for Biologics Evaluation and Research (CBER) that its Investigational New Drug (IND) application for IMM-529, a novel therapy targeting Clostridioides difficile infection, is under active FDA review. The regulator has requested additional clinical information, to which Immuron has responded with clarifications and minor adjustments to the trial protocol, ahead of the 30-day decision date for the IND.
Immuron also confirmed that topline data from its Phase 2 Travelan P2TD clinical study, conducted by the Uniformed Services University, has been delayed due to the recent U.S. government shutdown. The results are now expected by the end of November 2025. The findings will be pivotal in determining the company’s dosing strategy for its upcoming end-of-Phase 2 meeting with the FDA.
If results demonstrate improved efficacy from twice-daily dosing, Immuron plans to propose this regimen in future trials. If not, the existing three-times-daily schedule will likely be maintained.
Travelan, an orally administered passive immunotherapy designed to prevent travellers’ diarrhoea, has undergone multiple controlled studies across various doses and formulations. Earlier double-blind placebo-controlled trials have demonstrated protection rates of up to 90 per cent against diarrhoea and significant reductions in abdominal pain and fever among study participants.
The ongoing P2TD trial, enrolling 851 participants, uses a powdered version of Travelan (IMM-124E) administered twice daily. The results will help refine dosing recommendations and inform the next phase of regulatory review.
Immuron’s second clinical program, IMM-529, aims to prevent or treat recurrent Clostridioides difficile infection (CDI), a serious hospital-acquired condition. Developed in collaboration with Monash University researchers, IMM-529 utilises antibodies derived from hyperimmune bovine colostrum that target multiple virulence factors, including C. diff toxins, spores, and surface proteins.