FDA Approves IND Application for Immuron’s IMM-529 to Treat C. difficile Infection
Reuters
Nov 05
FDA Approves IND Application for Immuron's IMM-529 to Treat C. difficile Infection
Immuron Limited has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for IMM-529, allowing the company to proceed with a Phase 2 clinical trial targeting Clostridioides difficile infection (CDI). The IND approval enables Immuron to begin clinical development of IMM-529, which is designed to prevent and treat CDI, including recurrent cases. IMM-529 utilizes antibodies derived from hyperimmune bovine colostrum and has demonstrated promising results in pre-clinical models for prevention, protection against recurrence, and treatment of CDI. The Phase 2 trial is expected to start in the first half of 2026. No other organizations were mentioned as recipients of the regulatory approval.
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