BioInvent International AB announced on 6 May 2009 that its therapeutic antibody product candidate BI-204 (anti-oxLDL) has reached the primary endpoint in its phase I trial, and was safe and well tolerated. These positive results will now support a decision regarding whether to progress to phase II.
The objectives of the double-blind, within-group randomised dose-escalation trial were to determine the safety and tolerability of BI-204, as well as evaluation of pharmacokinetic parameters in order to help set dosage of the drug in future phase II trials.
Pharmacokinetic results showed the half life was in the expected range for fully human antibodies. The study, conducted in Denmark, involved a total of 80 healthy patients with elevated LDL cholesterol. The drug is being codeveloped with Genentech, a wholly-owned member of the Roche Group, under an agreement signed in January 2007. Under the terms of the agreement, Genentech obtained commercialisation rights for North America while BioInvent has retained the rights for the rest of the world.
BI-204 is a monoclonal antibody which targets oxidised forms of LDL cholesterol. In preclinical studies it has reduced inflammatory processes and plaque formation significantly. It is being developed as a potential drug for secondary prevention of cardiac events, such as death, heart attack or stroke, in high-risk patients.
BI-204 is derived from BioInvent’s proprietary antibody library n-CoDeR. The antibody targets oxidised forms of a lipoprotein (apoB100), which is a component of the LDL particle. Results support that the mechanism behind BI-204 is a modulation of the inflammatory process, resulting in a reduction of proinflammatory cells in treated plaques, which in turn leads to a reduction in new plaque formation and the regression of existing plaques. It is being developed as a drug for the secondary prevention of cardiac events, such as heart attack or stroke, in high-risk patients.