AstraZeneca has offloaded a midphase cardiovascular disease drug to Regio Biosciences. After getting a look at phase 2a data on MEDI5884, AstraZeneca has decided to license the antibody to the startup for use in a peripheral artery disease (PAD) study.
MEDI5884, now known as REG-101, is designed to block endothelial lipase and thereby boost the quantity and quality of functional HDL. As HDL absorbs cholesterol and takes it to the liver for removal from the body, the mechanism of action could help treat cardiovascular problems such as the hardening of the arteries.
AstraZeneca generated evidence that MEDI5884 increases HDL in patients with stable coronary artery disease on high-intensity statin therapy in a phase 2a clinical trial. The study linked the antibody to a 51% increase in HDL and a 26% rise in global cholesterol efflux.
While increases in LDL cholesterol and apolipoprotein B of 29% and 13%, respectively, were seen at the highest tested MEDI5884 dose, the researchers downplayed the finding, noting that no meaningful changes were seen at the potential target doses for future studies. Even so, the researchers said additional studies are needed to understand the implications of the rise in LDL.
Responsibility for taking the drug forward will now fall on Regio, a biotech co-founded by AstraZeneca veteran Rakesh Dixit, Ph.D. Backed by Hibiscus Capital Management and Innoforce, Regio plans to start a phase 2a trial of REG-101 in PAD patients in the second half of the year.
Regio has partnered with academic research organization CPC Clinical Research to run the phase 2a. Marc Bonaca, M.D., a cardiologist and executive director of CPC Clinical Research, set out the unmet need that REG-101 could address.
“Despite current standard of care therapies that address control of blood pressure, LDL cholesterol levels, and clotting risks, there are currently no available pharmacological treatments targeting reverse cholesterol transport to target the plaque that underlies the adverse effects negatively impacting millions of patients,” Bonaca said in a statement.