Lumen Bioscience, a clinical-stage biotechnology company developing biologic drugs for highly prevalent diseases, today announced clinical development progress for LMN-201, an investigational orally delivered cocktail to treat and prevent C. difficile infection (CDI). Achievements include FDA clearance of a planned Phase 2 study of LMN-201 and successful completion of a Phase 1 first-in-human study, which validated drug delivery of enteric capsules into the gut.
LMN-201 combines four therapeutic proteins—manufactured and orally delivered in the edible microorganism spirulina—that work synergistically to neutralize both the C. difficile bacterium and the toxin that causes its virulence. LMN-201 is the world’s first complex biologic cocktail to enter human clinical trials and represents a significant advance in the field of polypharmacology. Lumen recently published its pre-clinical data on LMN-201 on bioRxiv, pending peer review.
