Date: 2014-10-15
Type of information: Results
phase: 1
Announcement: results
Company: Actogenix (Belgium)
Product: AG014
Action
mechanism: AG014 is based on the expression and local delivery of the anti-TNF-alpha Fab certolizumab. AG014 is formulated as an enteric coated capsule, and is expected to combine excellent efficacy with a favorable safety profile. AG014 delivers the anti-TNF-alpha to the sites of mucosal inflammation in the colon and terminal ileum. AG014 is expected to combine the efficacy in IBD of injectable biological therapies such as anti-TNF-alpha antibodies with a much more favorable safety profile and no immunogenicity.
Disease: inflammatory bowel disease
Therapeutic area: Inflammatory diseases - Gastrointestinal diseases
Country:
Trial
details:
Latest
news: * On October 15, 2014, ActoGeniX, a clinical stage biopharmaceutical company, announced positive results of a Phase 1 study in healthy volunteers of AG014, an oral administration of the anti-TNF-alpha antibody certolizumab for Inflammatory Bowel Disease (IBD). The Phase 1 study results show that the product is safe and well tolerated while providing localized gastro-intestinal (GI) exposure. These favorable data provide further support for the clinical development of AG014 in IBD. ActoGeniX\'s proprietary ActoBiotics™ delivery platform, AG014 works by expressing and delivering the anti-TNF-alpha antibody certolizumab locally into the GI tract after oral capsule dosing. AG014 provides the advantage of a proven therapeutic approach in IBD without any of the systemic side effects, as the company\'s novel capsule formulation results in only localized mucosal presence of certolizumab without systemic exposure. The Phase 1 single-center, open-label study evaluated the safety and tolerability, medical endoscopic sampling methodology, and characterization of the pharmacokinetic profile of oral doses of AG014 in healthy volunteers. In addition to being safe and well tolerated, analysis of the pharmacokinetic profile by endoscopic sampling 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 data demonstrate 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. Furthermore, endoscopic sampling proved to be an efficient methodology for forthcoming pharmacokinetic evaluations in patients.
