REG-101 / AstraZeneca, Regio Biosciences - LARVOL DELTA

LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease. (PubMed, Arterioscler Thromb Vasc Biol) - P2a | "Inhibition of EL by MEDI5884 increases the quantity and quality of functional HDL in patients with stable coronary artery disease on high-intensity statin therapy without an adverse safety signal at the likely dose to be used. These data support further clinical investigation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03351738."

Clinical • Journal • P2a data • PK/PD data • Cardiovascular • Coronary Artery Disease • Dyslipidemia • APOB

Blocking endothelial lipase with monoclonal antibody MEDI5884 durably increases high density lipoprotein in nonhuman primates and in a phase 1 trial. (PubMed, Sci Transl Med) - "We then showed that a favorable lipoprotein profile of elevated HDL-C and reduced low-density lipoprotein cholesterol (LDL-C) could be achieved by combining MEDI5884 with a PCSK9 inhibitor. Last, when tested in healthy human volunteers, MEDI5884 not only raised HDL-C but also increased HDL particle numbers and average HDL size while enhancing HDL functionality, reinforcing EL neutralization as a viable clinical approach aimed at reducing CV risk."

Journal • P1 data • Cardiovascular • Dyslipidemia

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease (clinicaltrials.gov) - P2a; N=133; Completed; Sponsor: MedImmune LLC; Phase classification: P2 ➔ P2a

Clinical • Phase classification

LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of the Anti-Endothelial Lipase Antibody MEDI5884 in Subjects With Stable CAD (AHA 2019) - "A small increase in LDL-C but a decrease in small dense LDL was observed in MEDI5884 treated groups. Conclusions Inhibition of EL by MEDI5884 increases the quantity of functional HDL in subjects with stable CAD on high-intensity statin therapy without an adverse safety signal and warrants further clinical investigation to determine if it prevents progression of atherosclerosis."

Clinical • P2a data • PK/PD data • APOA1

Effects of a Neutralising Endothelial Lipase Monoclonal Antibody on Lipoprotein Metabolism in Nonhuman Primates and Healthy Volunteers (AHA 2019) - "Neutralisation of EL raised HDL-C and HDL particle number with parallel increases in ex vivo CEC and anti-inflammatory properties. These data are the first to demonstrate the effects of EL neutralisation in NHPs and humans. The data support further clinical development of MEDI5884 for the prevention of secondary cardiovascular events."

Clinical • APOA1

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease (clinicaltrials.gov) - P2; N=133; Completed; Sponsor: MedImmune LLC; Trial primary completion date: Jul 2018 ➔ Nov 2018

Clinical • Trial primary completion date