ActoBio Doses First Patient in Study of AG019

ctoBio Therapeutics have announced the first patient has been dosed in the Company's Phase Ib/IIa clinical trial for the treatment of early onset type 1 diabetes (T1D). ActoBiotics AG019 is a therapeutic agent designed to induce immune tolerance in T1D, a disease with no approved disease-modifying treatment, which is currently managed through lifestyle modification and diet, combined with exogenous insulin. "ActoBio's AG019 shows real potential for stemming the progression of type 1 diabetes and, in combination with new methods of identifying at risk populations, may provide an exciting opportunity to prevent clinical onset," Kevan Herold, MD, Professor of Immunobiology and of Medicine (Endocrinology) at Yale University said. "The successful outcome of clinical trials such as this one has the potential to reverse progression and entirely change the face of this disease." Professor Herold is also Executive Director of the Diabetes Center and Deputy Director of Translational Research at the Yale Center for Clinical Investigation and the US coordinating investigator for the AG019 study. AG019 is formulated as an easy-to-take capsule consisting of engineered Lactococcus lactis specifically modified to deliver human proinsulin and the tolerance-enhancing cytokine human interleukin-10 to the mucosal lining of the gastro-intestinal tissues. The microbe-based platform offers several advantages over injectable biologics including a unique delivery method of a therapeutic agent capable of inducing oral immune tolerance to reverse T1D. In the Phase Ib portion of the study, patients will receive AG019 alone. In the Phase IIa portion, patients that receive treatment with AG019 will also receive a short initial course of teplizumab, an anti-CD3 monoclonal antibody. Pre-clinical studies in mice have demonstrated that AG019, in association with a short-term treatment with systemic anti-CD3 monoclonal antibody, successfully induced reversion to normal blood sugar levels in 60% of diabetic mice, and effectively reversed the disease in 89% of mice treated at early stage. The Phase Ib/IIa study will be performed across a number of clinical sites specializing in the treatment of T1D in both the US and Belgium. Clinical trial results are expected at the beginning of 2020 and will provide data regarding the safety and efficacy of AG019 in humans.

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