BioInvent International has received IND clearance from the FDA to initiate a Phase II study for BI-204, a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls.
BI-204 is being co-developed with Genentech, a wholly-owned member of Roche, for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).
The Phase II study is a multicenter, randomized, double-blind, placebo-controlled study of intravenous BI-204 in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. The trial is designed to demonstrate a significant reduction in plaque inflammation following treatment with BI-204 as quantified by FDG-PET. The trial will enroll 120 patients with stable coronary vascular disease in centers in the U.S. and Canada. The results of the study are expected to be reported in the first half of 2012. Additional trials are being contemplated in patients with ACS prior to commencing Phase III.
BioInvent will receive a milestone payment of $15 million when the first patient is dosed in the Phase II study, expected to happen by the end of the year or early first quarter next year. A Phase I study for BI-204 was successfully completed in 2009, added the Lund, Sweden-based company.