IMM-529

July 6, 2026: Immuron Limited (ASX: IMC; NASDAQ: IMRN) announced it engaged Pullan Consulting to provide business development services aimed at securing a strategic partner for IMM-529, an orally delivered polyclonal antibody product being developed to prevent or treat Clostridioides difficile infection (CDI).

The company said the FDA has approved IMM-529’s Investigational New Drug application (IND 32095), enabling Phase 2 clinical development in CDI. Immuron reported it has completed the investigator brochure and clinical protocol, secured a principal investigator and three Australian trial sites, and manufactured/released drug product for clinical supply; the study is eligible to start via Australia’s Clinical Trial Notification (CTN) pathway.

Planned Phase 2 design: randomized, double-blind, placebo-controlled trial of IMM-529 + standard of care (SOC) vs placebo + SOC, enrolling up to 60 subjects with first-episode or recurrent CDI (2:1 randomization). Primary objective is safety/tolerability; efficacy assessments include mortality, symptoms, and recurrence rates.

Immuron cited preclinical infection/relapse model results for IMM-529 and stated it is seeking a licensing-style partner to fund development, registration, and commercialization.