MELBOURNE, Australia — November 5, 2025 — Leads & Copy — Immuron Limited (ASX: IMC; NASDAQ: IMRN) has received U.S. Food and Drug Administration (FDA) approval for its IMM-529 Investigational New Drug (IND) application, allowing a clinical study to proceed.
The FDA assigned IND number 032095 for the IMM-529 application, which is for clinical development of IMM-529 as a product to prevent or treat Clostridioides difficile infection (CDI).
The company plans to initiate a Phase 2 clinical trial for IMM-529 in individuals with CDI during the first half of 2026. The trial will be randomized, double-blind, and placebo-controlled, evaluating IMM-529 with Standard of Care (SOC) for treating first-episode or recurrent CDI. Up to 60 subjects will be enrolled at multiple sites in Australia, randomly assigned to IMM-529 + SOC or placebo + SOC in a 2:1 ratio.
The primary objective is to evaluate the safety and tolerability of IMM-529 together with SOC in patients with CDI or recurrent CDI. Efficacy will be assessed by measuring and comparing mortality rate, disease symptoms, and recurrence rate for each treatment group.
Lumanity’s assessment indicates that if efficacious, IMM-529 will be positioned early in the treatment algorithm, with a base case yearly revenue projected at US$400M. 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. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells.
Steven Lydeamore
Chief Executive Officer
steve@immuron.com
Source: Immuron
