Lumen Bioscience granted FDA fast track for C. difficile treatment

18-May-2023 - Last updated on 18-May-2023 at 13:23 GMT

Related tags Fda FDA approval Food and drug administration

Lumen Bioscience has announced that the US Food and Drug Administration (FDA) has granted fast track designation for LMN-201, its biologic drug to treat and prevent C. difficile infection (CDI).

LMN-201

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.

In addition, the capsule drug is taken orally, 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.

The FDA previously cleared a planned phase 2/3 study of LMN-201, which will begin enrolling approximately 375 patients at sites across the US 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.

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.

C. difficile infection

CDI is the most common health care-associated infection in US 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% to 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.

“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 Bio.

“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.”