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news.BioInvent has received IND clearance from the US Food & Drug Administration (FDA) to initiate a Phase II study for BI-204 which is being co-developed with Genentech for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).
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BI-204 is a human monoclonal antibody that specifically targets oxidised forms of a low-density lipoprotein (LDL) which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls.
BioInvent’s Phase II study is a multicenter, randomised, double-blind, placebo-controlled study of intravenous BI-204 in patients on standard-of-care therapy for stable atherosclerotic cardiovascular disease.
BioInvent said that 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 is expected to recruit 120 patients with stable coronary vascular disease in centers in the US and Canada.
BioInvent will receive a milestone payment of $15m 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.
BioInvent CEO Svein Mathisen said that BI-204, derived from BioInvent’s proprietary n-CoDeR antibody library, provides a new 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," Mathisen said.