MEDI4166 / AstraZeneca - LARVOL DELTA

MEDI4166, a novel antibody (PCSK9)-peptide (GLP-1) fusion molecule: single-ascending-dose study in patients with type 2 diabetes (EASD 2017) - P1; "Materials and In this multicenter, double-blind, placebo-controlled, single-ascending-dose study, 40 adult T2DM subjects receiving metformin monotherapy and LDL-c ≥70 mg/dL were randomized to 1 of 5 cohorts receiving SC MEDI4166 or placebo (MEDI4166, n = 6; placebo, n = 2 in each cohort). In this single-ascending-dose study in patients with T2DM, MEDI4166 had an acceptable safety profile, and dual target engagement was observed. Further investigation of this molecule in a multiple-ascending-dose study is ongoing."

Clinical • Diabetes

Engineering of a GLP-1 analogue peptide/anti-PCSK9 antibody fusion for type 2 diabetes treatment. (PubMed, Sci Rep) - "MEDI4166 showed robust and sustained LDL-C lowering in cynomolgus monkeys and exhibited the anticipated GLP-1 effects in T2D mouse models. We believe MEDI4166 is a novel molecule combining long acting agonist peptide and neutralising antibody activities to deliver a unique pharmacology profile for the management of T2D."

Journal

Randomised, phase 1, dose-finding study of MEDI4166, a PCSK9 antibody and GLP-1 analogue fusion molecule, in overweight or obese patients with type 2 diabetes mellitus. (PubMed, Diabetologia) - P1; "MEDI4166 was associated with an acceptable tolerability profile and significantly decreased LDL-cholesterol levels in a dose-dependent manner in overweight or obese patients with type 2 diabetes. However, there were no significant reductions in postprandial glucose levels at any dose of MEDI4166."

Clinical • Journal • P1 data