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Precigen ActoBio Announces Positive Topline Results from Phase 1b Study of AG019 ActoBiotics™, A Novel Therapy Designed to Address the Underlying Cause of Type 1 Diabetes
- Primary endpoint met assessing safety and tolerability in the Phase 1b monotherapy portion of the study - - Preliminary results demonstrate an encouraging
About this update from Precigen, Inc.
[{"type":"text","content":"- Primary endpoint met assessing safety and tolerability in the Phase 1b monotherapy portion of the study -\n - Preliminary results demonstrate an encouraging trend in C-peptide levels, a biomarker for T1D disease progression -\n - Preliminary data shows an increase in the frequency of islet-specific Tregs, a potential mechanistic indicator of therapeutic activity -\n\n\n GERMANTOWN, Md., Aug. 10, 2020 /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 it has met the primary endpoint assessing safety and tolerability in the Phase 1b monotherapy portion of the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics™ for the treatment of early-onset type 1 diabetes (T1D) (clinical trial identifier: NCT03751007, EudraCT 2017-002871-24). \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 consisting 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 tolerability of AG019 administered as a single dose and repeated daily doses as a monotherapy in adult and adolescent patients. The primary endpoint for assessing safety and tolerability is treatment-emerging adverse events (TEAEs) reported up to six months after treatment initiation. Nineteen patients were treated in the Phase 1b monotherapy portion of the study and 17 pati...