Immuron: FDA Approves IND Application For IMM-529

(RTTNews) - Immuron (IMRN) announced the FDA has approved Investigational New Drug application for IMM-529 and the Phase 2 clinical trial may proceed. The company plans to initiate a Phase 2 clinical trial for IMM-529 in individuals with Clostridioides difficile infection during the first half of 2026.

The Phase 2 clinical trial will be a randomized, double blind, placebo-controlled clinical study of IMM-529 with Standard of Care for the treatment of CDI in subjects with first episode CDI or recurrent CDI. Up to 60 subjects will be enrolled in the study.

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