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Precigen ActoBio Announces Positive Topline Results from Phase 1b/2a Study of AG019 ActoBiotics™, A Novel Therapy Designed to Address the Underlying Cause of Type 1 Diabetes
- Primary analysis data presented at the Federation of Clinical Immunology Societies (FOCIS) 2021 Virtual Annual Meeting - - Primary endpoint assessing safety
About this update from Precigen, Inc.
[{"type":"text","content":"- Primary analysis data presented at the Federation of Clinical Immunology Societies (FOCIS) 2021 Virtual Annual Meeting -\n - Primary endpoint assessing safety and tolerability met for both Phase 1b monotherapy and Phase 2a combination therapy portions of study -\n - AG019, as monotherapy and in combination with teplizumab, showed stabilization of C-peptide levels, a biomarker for T1D disease progression, and induced antigen-specific tolerance in conjunction with the reduction of disease-specific T cell responses -\n - Clinical trial assessing the efficacy of prolonged treatment of oral AG019 planned -\n\n\nGERMANTOWN, Md., June 10, 2021 /PRNewswire/ -- Precigen ActoBio, an innovative clinical-stage biotechnology company focused on a new class of microbe-based therapeutic agents and a wholly-owned subsidiary of Precigen, Inc. (Nasdaq: PGEN), today announced positive topline results for the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics™ for the treatment of recent-onset type 1 diabetes (T1D) (clinical trial identifier: NCT03751007, EudraCT 2017-002871-24). Results from the primary analysis were presented at the Federation of Clinical Immunology Societies (FOCIS) 2021 Virtual Annual Meeting by Kevan Herold, MD, Professor of Immunobiology and of Medicine at the Yale University.\n\n \n \n \n \n \n \n\n \nT1D is an autoimmune disease in which the immune system destroys insulin-producing beta cells in the pancreas, resulting in a blood glucose imbalance. There is no approved disease-modifying treatment for T1D, which is currently managed through lifestyle modification and diet combined with exogenous insulin. Replacement insulin therapy is associated with a variety of near- and long-term adverse events, as is failure to properly control glucose levels within a narrow range.\nAG019 is formulated as an oral capsule of engineered Lactococcus lactis specifically modified to deliver autoantigen human proinsulin (hPINS) and the tolerance-enhancing cytokine human interleukin-10 (hIL-10) to the mucosal lining of the gastrointestinal tissues. Administration of AG019 is designed to induce specific regulatory T cells (Tregs) that could reduce or eliminate the destruction of insulin-producing cells, potentially stabilizing or improving insulin production.\nThe Phase 1b open-label portion of the study evaluates the safety and...