Lumen Bioscience Receives Fast Track Designation for C. Difficile Drug

The FDA has granted Fast Track Designation for Lumen Bioscience’s LMN-201, an orally delivered biologic drug to treat and prevent C. difficile infection by neutralizing both the  bacterium and toxin that causes the infection’s virulence.

LMN-201 is intended to be administered simultaneously with standard-of-care antibiotics and for an additional eight weeks to provide protection from reinfection.

The FDA previously cleared Phase 2/3 study of LMN-201, which will enroll approximately 375 patients across the U.S. to start pivotal trials later in 2023.

The Fast Track Designation is meant to facilitate the development and expedite the review process of drugs to treat conditions that have an urgent, unmet need.

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