FDA Approves IND Application for Immuron’s IMM-529 to Treat C. difficile Infection
Immuron Limited has received FDA approval for its IND application for IMM-529, enabling a Phase 2 clinical trial for treating Clostridioides difficile infection (CDI). The drug, which uses antibodies from hyperimmune bovine colostrum, aims to prevent and treat CDI, including recurrent cases. The trial is set to begin in the first half of 2026. This announcement was made on November 05, 2025, and is for informational purposes only, not to be considered as financial or legal advice.
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. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immuron Limited published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9569254-en) on November 05, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
