The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Lumen Bioscience’s LMN-201, an investigational, orally delivered biologic drug to treat and prevent C. difficile infection (CDI).
LMN-201 combines four therapeutic proteins that act synergistically to neutralize both the C. difficile bacterium and the toxin that causes its virulence directly in the patient’s gastrointestinal tract. LMN-201 is taken orally (capsules), is compatible with standard-of-care antibiotics, and is GMP-manufactured by Lumen in Seattle. LMN-201 is intended to be administered concomitantly with normal antibiotics and for eight weeks thereafter to provide protection from reinfection while commensal bacteria recolonize the GI tract.
“Fast Track Designation 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. “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.”
The FDA previously cleared a planned Phase 2/3 study of LMN-201, which will begin enrolling approximately 375 patients at sites across the United States later this year. The study’s primary goal is recurrence prevention, although a secondary endpoint will also assess LMN-201’s ability to enhance primary treatment outcomes.