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Thursday, November 15, 2018

Novel Agent Lowers Lp(a), Meets All End Points in Phase 2

A novel antisense agent is relatively safe and highly effective in lowering levels of lipoprotein(a) in patients with both elevated Lp(a) and established cardiovascular disease (CVD), new research suggests.

In a dose-finding phase 2b trial that examined five regimens in more than 200 patients with CVD and Lp(a) levels of 60 mg/dL or higher. Treatment with the subcutaneous injectable drug known as AKCEA-APO(a)-LRX (Akcea Therapeutics/Ionis Pharmaceuticals) was associated with a dose-dependent effect on these levels from baseline to week 25 to 27, meeting the primary end point.

In addition, for the patients receiving the highest active dose evaluated, 20 mg/week, there was a mean 80% reduction in Lp(a) from baseline.

Lead author Sotirios Tsimikas, MD, vice president of Global Cardiovascular Development at Ionis Pharmaceuticals and professor of medicine at the University of California, San Diego, noted that this is especially dramatic compared with currently available treatments, including proprotein convertase subtilisin/kexin type 9 (PCSK-9) inhibitors.

"Looking at current therapies, PCSK-9 inhibitors lower Lp[a] by about 15% to 25% and niacin can lower it by 20% to 30%. So this is two to three times more potent than what's currently available to lower Lp(a)," Tsimikas told theheart.org | Medscape Cardiology.

Results also showed that 98% of the participants "got to goal," defined as Lp(a) less than 50 mg/dL. "This means almost everybody who got on the drug got to a level that we think has very low risk," Tsimikas said.

In addition, the 20 mg/week dose met all secondary outcomes, including mean change from baseline in low-density-lipoprotein cholesterol (LDL-C), ApoB, and oxidized phospholipids on apoB particles (OxPL-apoB and OxPl-apo[a]).

https://www.medscape.com/viewarticle/904891

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