Uniformed Services University to Release Topline Data

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Stock Immuron Ltd (IMC.ASX)
Release Time 10 Dec 2025, 9:11 a.m.
Price Sensitive Yes
 Uniformed Services University Releases Topline Data
Key Points
  • Primary endpoint did not reach statistical significance
  • Investigational product not administered as per Travelan® directions
  • Immuron to propose established three times daily dosing schedule
Full Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) announces that the Uniformed Services University has released topline results from its clinical trial evaluating the effectiveness of a third-party manufactured product containing enterotoxigenic E. coli (ETEC) hyperimmune bovine colostrum (IMM-124E) in maintaining gut health during deployment and travel. The investigational drug product, contract manufactured for USU by a third party, was formulated as 600 mg of powder in sachets and administered twice daily, which differs from the directions for use of Travelan®. The primary endpoint did not reach statistical significance. Immuron identifies several factors that may have influenced the outcome, including timing of dosing, compliance with study procedures, dosing adherence, and administration method. Immuron will propose the established and clinically validated three times daily dosing schedule for Travelan® at an upcoming End-of-Phase 2 meeting with the FDA. Immuron will continue to collaborate with the Naval Medical Research Command and the Walter Reed Army Institute of Research in the development of novel vaccines targeting Campylobacter and Shigella, and has advanced discussions with AFRIMS to conduct testing of Travelan® against EAEC and EPEC strains of E.coli.

Outlook

Immuron continues to market Travelan® assertively in its progression towards EBITDA (ex R&D) breakeven and has also advanced a Phase 2 clinical trial for IMM-529 in Clostridioides difficile infection following FDA approval of the IND.