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Precigen ActoBio Announces Additional Positive Interim Data from Phase 1b/2a Study of AG019 ActoBiotics™, A Novel Therapy Designed to Address the Underlying Cause of Type 1 Diabetes
- Latest results presented at the EASD 57th Annual Meeting - - AG019 monotherapy and AG019 combination therapy resulted in stabilization of HbA1c and IDAA1c
About this update from Precigen, Inc.
[{"type":"text","content":"- Latest results presented at the EASD 57th Annual Meeting -\n - AG019 monotherapy and AG019 combination therapy resulted in stabilization of HbA1c and IDAA1c levels, important indicators of long-term glycemic control associated with reduced risk of microvascular complications in T1D patients -\n - Mechanistic analysis showed AG019 treatment resulted in reduction of conventional T-cells with an inflammatory phenotype -\n - New metabolic results strengthen previously reported data on C-peptide and antigen-specific immune modulation for the AG019 monotherapy and AG019 combination therapy -\n - Monotherapy results suggest the potential for AG019 as a standalone therapeutic agent for T1D -\n\n\n\n \n GERMANTOWN, Md., Oct. 1, 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 additional positive interim data from 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 were presented in an oral presentation entitled, \"AG019 ActoBiotics as monotherapy or in association with teplizumab in recent-onset type 1 diabetes was safe and demonstrated encouraging metabolic and immunological effects\" at the European Association for the Study of Diabetes (EASD) 57th Annual Meeting by Chantal Mathieu, MD, PhD, Professor of Medicine at the Katholieke Universiteit Leuven, Belgium.\n\n \n \n \n \n \n \n\n \nThe 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 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). \nPreviously reported Phase 1b/2a topline data showed the potential of oral AG019 treatment to preserve insulin production in recent-onset T1D through its capacity to induce antigen-specific immune modulation:\nThe primary endpoint of both the Phase 1b AG019 monotherapy study and the Phase 2a AG019 combination therapy study was met. AG019 was well tolerated as a monotherapy and in...