ActoGeniX has reported positive results from a Phase I trial of AG014, an oral administration of the anti-TNF-alpha antibody certolizumab, to treat patients with inflammatory bowel disease (IBD).
According to the company, AG014 demonstrated high safety and tolerance levels while providing localised gastro-intestinal (GI) exposure.
The company’s ActoBiotics delivery platform, AG014, works by expressing and delivering the anti-TNF-alpha antibody certolizumab locally into the GI tract after an oral capsule dose.
The single-centre, open-label trial evaluated the safety and tolerability, medical endoscopic sampling methodology and characterisation 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 an oral capsule dosing, high levels of AG014 could be recovered in all relevant GI regions, including both the small and large intestine.
The positive 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.
In addition, endoscopic sampling proved to be an efficient methodology for forthcoming pharmacokinetic evaluations in patients.
ActoGeniX chief medical officer Dr Bernard Coulie said: "The positive results generated from this early study are highly significant for ActoGeniX.
"The data not only provides further support for the clinical development of AG014 in IBD, but they validate the company’s novel technology platform for the oral and localised 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."
The company uses the latest techniques in synthetic biology to generate orally available therapeutic proteins, designed to be safe, efficacious and more cost-effective than injectable protein drugs.