158-21 | HORIZON

Overview

“A Randomized Double-Blind, Placebo-Controlled, Multicenter Trial Assessing the Impact of Lipoprotein (A) Lowering with Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients with Established Cardiovascular Disease”

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Millions of people have elevated Lp(a), an independent inherited cardiovascular disease (CVD) risk factor. It is estimated that 20-30% of people who suffer from CVD have elevated Lp(a).[1],[2] Currently no treatment exists that specifically targets elevated Lp(a), and diet and other lifestyle changes are also not effective at reducing elevated levels.[3] Results of a Phase 2 study presented at AHA in November 2018 showed that TQJ230 significantly reduced Lp(a) in patients with high Lp(a) and pre-existing CVD.[4] Novartis plans to conduct a Phase 3 cardiovascular outcomes trial with the potential of addressing the Lp(a) patient community's unmet need for effective treatment.

"No treatments are currently available to substantially lower Lp(a). People with this inherited risk factor are facing cardiovascular risks that cannot be addressed effectively with lifestyle changes," said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. "We're excited about the novel, RNA-targeting approach that could be a game-changer for people with elevated Lp(a). If our Phase 3 trial succeeds, we expect that TQJ230 will become the leading treatment option and another pillar of our longstanding commitment to re-imagining cardiovascular medicine."