Therapeutic Protein Combo Fast Tracked for CDI Treatment, Prevention

Therapeutic Protein Combo Fast Tracked for CDI Treatment

The Food and Drug Administration (FDA) has granted Fast Track designation to LMN-201 for the treatment and prevention of Clostridioides difficile infection (CDI).

LMN-201 is an orally delivered biologic agent that is comprised of 3 antibody-like proteins that bind and neutralize both the C. difficile bacterium and the toxin that causes its virulence, as well as an enzyme protein that destroys the cell wall of the C. difficile bacterium itself. It is intended to be administered concomitantly with standard of care antibiotics.

The investigational agent will be evaluated in a phase 2/3 trial (ClinicalTrials.gov Identifier: NCT05330182) that is expected to enroll 375 patients later this year. The primary endpoint of the study is CDI recurrence prevention, which will be measured by the proportion of patients who achieve global cure (both successful initial CDI treatment and no CDI recurrence during the prevention and observation phases).

“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. “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’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments. The agency recently approved the first orally administered fecal microbiota therapy for CDI recurrence prevention.