BioInvent International AB announces the dosing of the first patient in the phase II study of the company's antibody, BI-204. The product candidate is being developed for secondary prevention of cardiovascular events in patients with acute coronary syndrome.
The phase II study is a multi-centre, randomized, double-blind, placebo-controlled study of BI-204, delivered intravenously to patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease. The trial will enrol 120 patients at approximately 20 centres in the United States and Canada. It is designed to demonstrate a reduction in plaque inflammation following treatment as quantified by FDG-PET imaging (18F 2 deoxyglucose positron emission tomography).
The antibody is being developed in collaboration with Genentech, a member of the Roche Group. BioInvent will receive a milestone payment of US$ 15 million from Genentech upon dosing of the first patient.
Svein Mathisen, CEO of BioInvent, commented: “BI-204 originates from BioInvent's proprietary n-CoDeR library and it represents an innovative approach to potentially reducing cardiac events in patients with coronary heart disease. The results from this phase II clinical trial will provide further insights into BI-204's ability to reduce plaque inflammation and how it potentially can add to current treatment of coronary heart disease.”
BI-204 (anti-oxLDL, MLDL1278A, RG7418) is a human antibody 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. LDL is known as “bad cholesterol”. Research in recent years has shown strong links between these oxidised particles and harmful inflammatory processes in the vessel walls. Such inflammation results in the formation of atherosclerotic plaque that may fragment and cause blood clots.
Results support that the mechanism behind BI-204 is a modulation of the inflammatory process, resulting in a reduction of pro-inflammatory 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 cardiovascular events, such as heart attack or stroke in patients with acute coronary syndrome. BI-204 is being developed in collaboration with Genentech, Inc., a member of the Roche Group.
BioInvent International AB, is a research-based pharmaceutical company that focuses on developing antibody drugs and currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis.