AG014 Safe and Well Tolerated, Successful Localized GI Delivery of Drug With No Systemic Exposure
GHENT, Belgium I October 15, 2014 I ActoGeniX, a clinical stage biopharmaceutical company, today 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.
Dr. Bernard Coulie, Chief Executive Officer and Chief Medical Officer of ActoGeniX commented, “The positive results generated from this early study are highly significant for ActoGeniX. 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. As such, we look forward to moving forward with our development plan for AG014.”
About ActoGeniX
ActoGeniX is a biotech company that uses proprietary leading-edge techniques in the area of synthetic biology to generate orally available therapeutic proteins that are designed to be safe, efficacious and more cost-effective than injectable protein drugs. Specifically, the platform uses Lactococcus lactis, a safe food grade bacteria commonly used in the dairy industry, to orally deliver one or more therapeutic peptides and proteins, including cytokines, enzymes, hormones and monoclonal antibodies in a single formulation.
ActoGeniX has confirmed the broad applicability of its technology platform for a wide range of serious conditions, including oral, gastrointestinal, metabolic, immune and allergic diseases. The technology also allows for the potential modulation of bacteria found in the human microbiome, thought to be implicated in various diseases. The company can generate IND-ready, orally available, therapeutic proteins in less than 18 months providing a best-in-class platform for building a drug pipeline.
The Company’s pipeline includes AG014, an oral anti-TNF alpha for the treatment of IBD, as well as AG013, a Phase 2-ready orphan drug (EU) for the treatment of oral mucositis in Head & Neck cancer patients. Additional programs include treatments for celiac disease, Type 1 diabetes, C. difficile, colon cancer, and targeted microbiome modulation.
ActoGeniX was founded in 2006 in Ghent (Belgium) and currently has 22 employees. The company has raised €46 million (approximately $60 million) in three equity financing rounds from a consortium of leading European life sciences investors.
SOURCE: ActoGeniX
Post Views: 226
AG014 Safe and Well Tolerated, Successful Localized GI Delivery of Drug With No Systemic Exposure
GHENT, Belgium I October 15, 2014 I ActoGeniX, a clinical stage biopharmaceutical company, today 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.
Dr. Bernard Coulie, Chief Executive Officer and Chief Medical Officer of ActoGeniX commented, “The positive results generated from this early study are highly significant for ActoGeniX. 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. As such, we look forward to moving forward with our development plan for AG014.”
About ActoGeniX
ActoGeniX is a biotech company that uses proprietary leading-edge techniques in the area of synthetic biology to generate orally available therapeutic proteins that are designed to be safe, efficacious and more cost-effective than injectable protein drugs. Specifically, the platform uses Lactococcus lactis, a safe food grade bacteria commonly used in the dairy industry, to orally deliver one or more therapeutic peptides and proteins, including cytokines, enzymes, hormones and monoclonal antibodies in a single formulation.
ActoGeniX has confirmed the broad applicability of its technology platform for a wide range of serious conditions, including oral, gastrointestinal, metabolic, immune and allergic diseases. The technology also allows for the potential modulation of bacteria found in the human microbiome, thought to be implicated in various diseases. The company can generate IND-ready, orally available, therapeutic proteins in less than 18 months providing a best-in-class platform for building a drug pipeline.
The Company’s pipeline includes AG014, an oral anti-TNF alpha for the treatment of IBD, as well as AG013, a Phase 2-ready orphan drug (EU) for the treatment of oral mucositis in Head & Neck cancer patients. Additional programs include treatments for celiac disease, Type 1 diabetes, C. difficile, colon cancer, and targeted microbiome modulation.
ActoGeniX was founded in 2006 in Ghent (Belgium) and currently has 22 employees. The company has raised €46 million (approximately $60 million) in three equity financing rounds from a consortium of leading European life sciences investors.
SOURCE: ActoGeniX
Post Views: 226
