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CLB-004 is an investigational oral drug being developed by ClostraBio, a spinout from the University of Chicago. It consists of a polymeric block copolymer nanoparticle platform designed to deliver butyrate, a short-chain fatty acid, specifically to the lower gastrointestinal tract, including the ileum, cecum, and colon. The active ingredient, butyrate, is covalently attached to block copolymers that self-assemble into nanoscale micelles, allowing for controlled and sustained release while masking the foul odor and taste of free butyrate. CLB-004's mechanism of action involves restoring intestinal barrier function through butyrate-mediated induction of interleukin-22 (IL-22), support of tight junction integrity, and differentiation of regulatory T cells (Tregs). It is currently in IND-enabling development for the treatment of mild-to-moderate ulcerative colitis and other non-communicable chronic gut diseases.
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