nontoxigenic Clostridioides difficile strain M3

NTCD-M3 is a live biotherapeutic product being developed for the prevention of recurrent Clostridioides difficile infection (CDI). [2, 5, 8] It consists of an oral formulation of spores from a naturally occurring, non-toxigenic strain of the C. difficile bacterium (strain M3), which does not possess the genes required to produce toxins. [7, 8] Administered orally as a capsule or suspension after a patient has completed antibiotic treatment for CDI, NTCD-M3 colonizes the gastrointestinal tract. [10, 14] This colonization competitively inhibits the growth and proliferation of pathogenic, toxin-producing C. difficile strains, effectively acting as a temporary "ground cover" that prevents CDI recurrence while allowing the patient's native gut microbiome to recover. [8, 13] Clinical studies have shown that colonization with NTCD-M3 significantly reduces the rate of CDI recurrence compared to placebo. [1] The asset was originally developed by ViroPharma (as VP20621) and has since been part of the pipelines of Shire and Takeda through acquisitions. [11] Destiny Pharma acquired the asset in 2020 and is co-developing it with Sebela Pharmaceuticals, which holds the rights for North America. [9]

Other names

Non-toxigenic Clostridium difficile strain M3Non-toxigenic C. difficileBacteria replacements (as a class descriptor)