FDA Grants Lumen Bioscience Fast Track Designation for Oral Biologic

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Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

On May 17, 2023, US-based Lumen Bioscience, a clinical-stage biotechnology company, announced that FDA has granted fast track designation to LMN-201, an investigational, orally delivered biologic drug in development by Lumen for treating and preventing Clostridioides difficile (C. difficile) infection (CDI).

LMN-201 is expected to begin a planned Phase II/III study in the United States in 2023. The biologic drug candidate combines four therapeutic proteins that act synergistically to neutralize both the C. difficile bacterium and the toxin that causes the bacterium’s virulence directly in the patient’s gastrointestinal (GI) tract. According to a company press release, the biologic is taken orally (capsules) and is compatible with standard-of-care antibiotics.

LMN-201 is intended to be administered concomitantly with normal antibiotics. It is intended to be used for eight weeks following initial dose to provide protection from reinfection during the period when commensal bacteria recolonize the GI tract. The biologic is manufactured by Lumen at its site in Seattle, Wash., in compliance with good manufacturing practices.


“Fast [t]rack [d]esignation underscores the significant unmet need for treating and preventing C. difficile infection and the potential of LMN-201 to address this persistent gap in patient care,” said Brian Finrow, co-founder and CEO of Lumen Bioscience, in the press release. “Recent advances in CDI recurrence prevention are inspiring but have yet to make a perceivable impact on the epidemic, due in significant part to inconvenient administration requirements. We are committed to advancing our clinical program and bringing this innovative therapy to patients as quickly as possible, to provide relief to those suffering from this life-threatening disease.”

Source: Lumen Bioscience