The US Food and Drug Administration (FDA) approved an investigational new drug (IND) for oral ActoBiotics AG017 capsules from ActoBio Therapeutics.
The drug contains a form of bacterium Lacotococcus lactic, which is specifically engineered to express a gliadin peptide in combination with an immunomodulating cytokine.
ActoBiotics programs are currently used to induce antigen-specific immune tolerance that can prevent or reverse certain autoimmune and allergic diseases. AG017 is an antigen-specific investigational immunotherapy candidate with the potential to reverse gluten sensitivity, ActioBio stated.
The drug will enter a Phase Ib/IIa study in patients with celiac disease in the US and Europe later in 2019.
The ActoBio approach enables biologics to be orally or topically administered to provide an alternative means of delivery over injectable biologics.
Celiac disease is a chronic intestinal inflammatory disorder that is caused by an autoimmune reaction triggered by the ingestion of gluten proteins. According to the company, over 90% of patients with celiac disease have an HLA-DQ2.5 genotype that responds to its immunomodulating cytokine.
There is currently no FDA-approved drug for the disease, but many patients live with a strict diet that eliminates all gluten. However, ActoBio suggested that its investigational treatment may allow patients to no longer need to remove gluten from their diets.