Novartis is adding more weight onto its Ionis-hitched saddle, tacking on a next-generation cardiovascular disease treatment meant to be the sequel to pelacarsen.
The new collaboration disclosed Thursday will see Novartis pay $60 million in upfront cash plus an undisclosed amount of milestones. Novartis will have sole responsibility to develop, manufacture and ultimately commercialize the asset, aimed at patients with elevated lipoprotein (a) levels.
“This collaboration is designed to leverage Ionis’ advancing RNA-targeting platform technologies to deliver a novel Lp(a)-targeting therapy that we expect will provide industry-leading efficacy and dosing frequency,” Ionis CEO Brett Monia, Ph.D., said in a release.
The deal speaks volumes not just about Novartis’ confidence in this new compound but also in the ongoing phase 3 cardiovascular outcomes trial for pelacarsen in patients with elevated lipoprotein(a) levels. Those protein levels are considered a genetic driver of cardiovascular disease and are decided at birth, unmoved by lifestyle changes. Pelacarsen works by blocking the production of apolipoprotein(a), a protein that makes up the structure of Lp(a).
Pelacarsen stems from a 2017 deal between Novartis and Ionis’ subsidiary Akcea Therapeutics, through which Novartis gained the option to sign onto both pelacarsen and what’s now olezarsen. Novartis opted into its licensing rights for pelacarsen two years later in 2019. No financial details of the deal were disclosed in either 2017 or 2019.
In addition to the cardiovascular outcomes trial, Novartis is testing pelacarsen in a phase 3 trial in Germany to see whether or not treatment reduces patients’ need for lipoprotein apheresis, a process where lipoprotein is physically removed from the blood. A separate phase 2 trial, assessing pelacarsen’s ability to stymie the progression of calcific aortic valve stenosis, was recently delayed five months—the trial was set to start in September 2023 and will now launch in March 2024.
The cardiovascular outcomes trial completed enrollment in July 2022 and is expected to readout in 2025, with 8,300 patients previously expected to participate.