— Orally delivered biologic drug for treatment and prevention of C. difficile infection
— LMN-201 to start pivotal trials in 2023
Seattle, WA, May 17, 2023 – Lumen Bioscience—a clinical-stage biotechnology company developing biologic drugs for highly prevalent diseases—today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 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. Physicians interested in participating are encouraged to contact Lumen’s clinical operations team at email@example.com. The double-blind, placebo-controlled study will assess LMN-201’s ability to both improve treatment outcomes and prevent recurrence in recently diagnosed CDI patients. Prior CDI recurrence is not required for enrollment.
About Fast Track Designation
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and to fill unmet medical needs. The purpose is to get important new drugs to the patient earlier. Companies that receive Fast Track Designation are eligible for several potential benefits, including more frequent meetings and interactions with the FDA during clinical development; eligibility for accelerated approval and priority review, if relevant criteria are met; and rolling review of completed sections of a biologics license application.
About C. difficile infection (CDI)
CDI is the most common health care-associated infection in U.S hospitals, causing nearly half a million cases and more than $5 billion in healthcare costs annually. Antibiotic therapy is typically successful for initial cases of CDI. However, 20%-40% of patients will suffer a recurrence, and the chance of additional episodes for these patients can exceed 40%. Currently available approaches for preventing CDI are hampered by high costs and inconvenient delivery (in most cases requiring either I.V. administration for traditional antibodies or bowel prep or enema for fecal microbiota transplant).
LMN-201 is a cocktail of two classes of therapeutic proteins: the world’s first complex biologic cocktail drug. The first class is comprised of three antibody-like proteins that bind and neutralize the bacterial toxin that is the main cause of diarrhea and other severe symptoms of CDI. The second is an enzyme protein that destroys the cell wall of the C. difficile bacterium itself. The product is orally delivered in capsules and shelf stable, facilitating ready distribution to broader patient populations than is feasible with most other interventions available or in development for CDI. Lumen has published its pre-clinical data on LMN-201 on bioRxiv (pending peer review).