PGN-001 + adalimumab

PGN-001 + adalimumab is an investigational drug–device combination approach in which a proprietary liquid formulation of adalimumab (PGN-001) is delivered locally to the colon, using Progenity/Biora Therapeutics’ ingestible Drug Delivery System (DDS) capsule or surrogate local administration, for the treatment of ulcerative colitis and other inflammatory bowel diseases. PGN-001 itself is a variant/liquid formulation of adalimumab, a fully human IgG1 monoclonal antibody that binds tumor necrosis factor alpha (TNF-α) and blocks its interaction with TNFR1 and TNFR2, thereby suppressing TNF-driven intestinal inflammation.[1][2][8][10][16][19] Local colonic delivery aims to maximize drug levels at the site of disease while minimizing systemic exposure and toxicity, as supported by preclinical colitis models in which intracecal administration of PGN-001 adalimumab drug substance reduced colonic TNF-α without measurable systemic levels.[1] The combination is being developed by Progenity (now Biora Therapeutics) within its NaviCap targeted therapeutics platform as an orally delivered anti-TNF strategy for ulcerative colitis.[1][4][10][16][19]