Immuron Limited Announces Planned IND Submission to FDA for IMM-529 Targeting C. difficile Infection, Paving Way for Phase 2 Clinical Trials
Reuters
Oct 02
Immuron Limited Announces Planned IND Submission to FDA for IMM-529 Targeting C. difficile Infection, Paving Way for Phase 2 Clinical Trials
**Immuron Limited Updates Regulatory Progress on Key Projects** MELBOURNE, Australia - Immuron Limited (ASX: IMC; NASDAQ: IMRN), a global biopharmaceutical company, has announced significant progress in its regulatory pipeline. The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its candidate IMM-529, targeting Clostridioides difficile infection, in mid-October 2025. Approval of this IND will enable Immuron to initiate a Phase 2 clinical program. Additionally, initial pre-clinical research studies for IMM-986, aimed at treating Vancomycin-resistant Enterococci $(VRE)$, are on track for completion by year-end 2025. Immuron also confirmed that its Travelan® product, currently imported into the U.S. as a dietary supplement, is not affected by new U.S. pharmaceutical tariffs. No new grant or funding has been announced, and the updates relate solely to Immuron Limited's own regulatory progress.
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