On August 19th, 2019, ActoBio Therapeutics, Inc. announced that the FDA has given its permission to an Investigational New Drug (IND) application for Actobiotics® AG017, an orally-delivered therapeutic for the treatment of celiac disease. AG017 is an antigen-specific investigational drug with the potential to reverse gluten sensitivity. ActoBio plans to enroll about 42 celiac disease patients in its Phase 1b/2a study in the U.S. and Europe later this year.

ActoBiotics® aims to address unmet needs in a wide range of autoimmune and allergic diseases through initiation of antigen-specific immune tolerance that can prevent, impede, or reverse the disease. The target population for this clinical trial is celiac disease patients with an HLA-DQ2.5 genotype whose symptoms are well-controlled on the gluten-free diet.

ActoBiotics® AG017 for the treatment of celiac disease will be the second antigen-specific investigational immunotherapy drug in clinical development following ActoBiotics® AG019, which is currently in a Phase 1b/2a clinical study for the treatment of type I diabetes.

In their press release, Pieter Rottiers, PhD, Chief Executive Officer of ActoBio Therapeutics™ stated, “We are delighted to be moving forward and entering clinical trials with our ActoBiotics® AG017 for celiac disease. We have demonstrated that this product is safe and efficacious in animal studies. Our approach with AG017 is to target the underlying cause of celiac disease, and this next stage of the program will allow us to evaluate how our preclinical results will translate in patients.”

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ActoBio Announces Phase 1b/2a Trial for ActoBiotics® AG017