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 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 an upfront payment of US $15 million and BioInvent is also entitled to further milestone payments of up to US $175 million as well as royalties on sales in North America.