BI-204
Product description
BI-204 is a human antibody which targets the oxidised form of a
low-density lipoprotein (LDL), called apoB100. BI-204 is being
developed as a treatment for atherosclerosis, aimed at reducing the
occurrence of heart attacks in high-risk patients. These are
primarily patients with acute coronary artery disease, particularly
those who have already suffered a heart attack.
Product rationale
Oxidised LDL plays a major role in the development of
atherosclerotic plaques. The molecule can lead to harmful
inflammatory processes occurring within the blood vessel wall.
Through targeting oxidised LDL, BI-204 can prevent this
inflammation.
Based on preclinical studies, BI-204 is expected to not only prevent the growth of atherosclerotic plaques, but also to reduce the size of existing plaques and prevent the break down of unstable plaques.
Clinical status
A Phase II clinical trial was initiated in March 2011. It 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 and 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.
A Phase I study in 80 healthy volunteers with elevated levels of LDL has been completed in Denmark. The study met its primary endpoint demonstrating that BI-204 is safe and well tolerated. The trial was a double blind, placebo-controlled, dose-escalation study. Single and multiple doses of BI-204 have been administered to patients either intravenously or subcutaneously.
Preclinical studies showed that administering BI-204 could substantially reduce the formation of atherosclerotic plaques by over 50%. The drug also reduced the size of plaques already present by 50% over four weeks.
Development and commercialisation
strategy
BioInvent has entered into a strategic collaboration with
Genentech, Inc. to co-develop and commercialise BI-204. Under the
terms of the agreement, the two companies are jointly responsible
for clinical development. Genentech has licensed the
commercialisation rights for North America. BioInvent has retained
the rights for the rest of the world.
Genentech has made cash payments of in total US $30 million so far, and BioInvent is also entitled to further milestone payments of up to US $160 million as well as royalties on sales in North America.