Precigen, Inc. (NASDAQ:PGEN) shares rose Friday after the company disclosed positive topline results for the ongoing Phase 1b/2a clinical study investigating AG019 ActoBiotics™ for the treatment of recent-onset type 1 diabetes.
The Germantown, Maryland-based company said its Precigen ActoBio subsidiary 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.
T1D 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.
The Phase 1b open-label portion of the study evaluates the safety and tolerability of AG019 as a monotherapy in adult (age 18-42) and adolescent (age 12-17) patients. The primary endpoint for assessing safety and tolerability is treatment-emerging adverse events (TEAEs) reported up to 6 months post treatment initiation.
The Phase 2a double-blind portion of the study investigates the safety and tolerability of AG019, in combination with an investigational anti-CD3 monoclonal antibody , teplizumab (PRV-031).
PGEN shares jumped $1.50, or 21.5%, to $8.49.