Phase III trial of Leqvio in ASCVD patients meets key primary endpoints : Novartis

Novartis has announced that its Phase III V-MONO trial of Leqvio (inclisiran), an siRNA therapy, met its primary endpoints. The six-month, randomized, double-blind trial involved 350 patients, comparing Leqvio, ezetimibe, and a placebo. Patients were assigned to receive Leqvio, ezetimibe, or a placebo in a 2:1:1 ratio.

The trial’s primary endpoint was the change in LDL-C levels from baseline to day 150. Leqvio significantly reduced LDL-C compared to both placebo and ezetimibe. This is the first study to evaluate siRNA therapy as a monotherapy for lowering LDL-C in people at low or moderate risk of atherosclerotic cardiovascular disease (ASCVD).

Novartis will discuss these findings with regulatory bodies like the FDA and continue to explore Leqvio’s potential in cardiovascular prevention. The company holds worldwide rights to Leqvio through a partnership with Alnylam Pharmaceuticals. In May, Novartis also reported positive Phase III results for remibrutinib in chronic spontaneous urticaria.