BioInvent Reports Positive Phase I Results for BI-204
News May 12, 2009
BioInvent International AB announces 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 Phase I results will now support a decision regarding whether to progress to Phase II.
The objectives of the double-blind, within-group randomized 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 co-developed with Genentech, Inc., a wholly-owned member of the Roche Group, under an agreement signed in January 2007. Under the terms of the agreement, Genentech obtained commercialization rights for North America while BioInvent has retained the rights for the rest of the world.
BI-204 is a monoclonal antibody which targets oxidized 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.