BioInvent Reports Positive Phase I Results for BI-204, in Development for Prevention of Cardiovascular Conditions Associated with Atherosclerosis
Published: May 06, 2009
The objectives of the double-blind, within-group randomised 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 commercialisation rights for North America while BioInvent has retained the rights for the rest of the world.
BI-204 is a monoclonal antibody which targets oxidised 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.
Svein Mathisen, CEO of BioInvent, commented, “These Phase I results showing safety and tolerability, along with the preclinical data indicating a significant reduction in atherosclerotic plaque burden, add to our belief that BI-204 could reduce mortality and morbidity for patients with acute coronary artery disease. We believe that there are no effective drugs currently available that have a significant effect on the root cause of the disease once it is established. We are finalising preparations for a potential Phase II clinical trial program and hope to bring this candidate a step closer to potential commercialisation with our collaborator Genentech.”
For further information, please contact: BioInvent International AB Svein Mathisen President & CEO Tel: +46 (0)46-286 85 67 Mobile: +46 (0)708-97 82 13 E-mail: email@example.com