Monoclonal antibodies delivered orally and with much better bioavailability
Our formulation for oral delivery of monoclonal antibodies and other macro-molecules has been tested in 3 preclinical studies in 2 different animal species and has shown impressive pharmacokinetics, i.e. (1) much higher bioavailability than subcutaneously administered mAb and (2) linear pharmacokinetics. The formulation has an established composition (with favorable GI tract absorption) and morphology that is obtained by application of scCO2 spray drying technology. The particles obtained, in which the mAb is captured, are dosed orally in an enteric coated solid dosage form, which passes the stomach unchanged and makes the particles available for uptake in the duodenum.
Analytical data have shown that the mAbs captured in the particles have unchanged structure and functionality. The preclinical studies have shown that besides a better bioavailability, the functionality and structure of the mAbs after oral administration match with subcutaneous administration.
First human clinical studies are planned for 2020.