BioInvent receives FDA IND clearance for BI-204 Phase II trial in cardiovascular disease

BioInvent International AB (OMXS: BINV) today announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) 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 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. Inflammation plays a critical role in the pathogenesis of atherosclerosis. The trial is designed to demonstrate a significant reduction in plaque inflammation following treatment with BI-204 as quantified by FDG-PET (¹⁸F 2-deoxyglucose positron emission tomography). The trial will enrol 120 patients with stable coronary vascular disease in centers in the United States and Canada. The topline 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. The study was a double-blind, within-group randomised dose-escalation trial testing both single and multiple doses of BI-204 administered either intravenously or subcutaneously. In total, 80 healthy male or female subjects with elevated levels of LDL cholesterol were included in the trial. BI-204 was well tolerated and pharmacokinetic results showed the half-life was in the expected range for fully human antibodies.

Svein Mathisen, CEO of BioInvent, commented: "Despite the development of a wide array of therapeutic interventions for coronary artery disease, including statins, this disease remains a major cause of death in the developed world and represents a significant unmet medical need. BI-204, derived from BioInvent's proprietary n-CoDeR^® antibody library, provides a novel and unique therapeutic approach potentially reducing cardiac events in high risk patients. Following successful FDA approval of the IND for our clinical program, we are optimistic for the future commercialisation of BI-204, in partnership with Genentech, which we hope will provide improved outcome for patients."