ActoGeniX reports positive results from Phase I trial of AG014 to treat inflammatory bowel disease

The results show that AG014 is safe and well tolerated while providing localized gastro-intestinal (GI) exposure.

AG014 is the company’s ActoBiotics delivery platform and works by expressing and delivering the anti-TNF-alpha antibody certolizumab locally into the GI tract after oral capsule dosing.

The single-center, open-label trial assessed the safety and tolerability, medical endoscopic sampling methodology and characterization of the pharmacokinetic profile of oral doses of AG014 in healthy volunteers.

The analysis of the pharmacokinetic profile by endoscopic sampling also showed that following oral capsule dosing, high levels of AG014 could be recovered in all relevant GI regions, including both the small and large intestine.

The results also show that live AG014 bacteria are released at the targeted site in the GI tract, and while moving through the alimentary tract, produce and deliver the anti-TNF-alpha antibody certolizumab locally to the GI tract.

Additionally, endoscopic sampling proved to be an efficient methodology for forthcoming pharmacokinetic evaluations in patients.

ActoGeniX chief executive officer and chief medical officer Dr Bernard Coulie said the positive results generated from this early study are highly significant for the company.

"The data not only provide further support for the clinical development of AG014 in IBD, but they validate the company’s novel technology platform for the oral and localized mucosal delivery of biotherapeutics that will potentially address the needs of patients suffering from gastrointestinal and immunological diseases including IBD, celiac disease and Type 1 diabetes," Coulie said.

"As such, we look forward to moving forward with our development plan for AG014."