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Agent reduces Lp(a) levels in phase 2 study

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Sotirios Tsimikas

Akcea Therapeutics Inc. announced that a phase 2 study of AKCEA-APO(a)-L_RX showed that the drug was tolerable and lowered lipoprotein(a) levels in patients with CVD.

The topline results were announced in advance of a late-breaking clinical trial presentation scheduled for the American Heart Association Scientific Sessions in November.

“These data represent an important step forward for patients who have significant risk of premature death from cardiovascular disease due to their high levels of Lp(a),” Paula Soteropoulos, CEO of Akcea Therapeutics, said in a press release. “In this large phase 2 study, AKCEA-APO(a)-L_Rx, robustly lowered Lp(a) with a favorable safety and tolerability profile. In addition, the data from this study support the potential to treat patients with convenient, low-volume monthly doses.”

The phase 2 clinical study is a randomized, double-blind, placebo-controlled, dose-ranging study of 286 patients with CVD and high Lp(a) (mean baseline levels, 100 mg/dL), meant to test the safety and tolerability of AKCEA-APO(a)-L_RX while informing dose and dose frequency selection for the phase 3 CV outcomes study, according to the release. Patients were treated for 6 months to 1 year.

The efficacy finding showed dose-dependent reductions of Lp(a) compared with placebo at all dose levels, including low monthly doses of AKCEA-APO(a)-L_RX, with most patients in the active group achieving Lp(a) reductions below the threshold of risk for CVD events. The safety finding showed that adverse effects were similar between the active and placebo groups with the most common adverse event being an injection site reaction. No patients experienced a confirmed platelet level of less than 100,000/mm³ and the incidence of platelet levels less than 140,000/mm³ was comparable between the active and placebo groups, according to the release.

“Those of us who are on the front lines treating patients with elevated Lp(a) who have aggressive, premature heart disease recognize the significant need for a treatment like AKCEA-APO(a)-L_Rx,” Sotirios Tsimikas, MD, FACC, FAHA, FSCAI, vice president of global cardiovascular development at Ionis Pharmaceuticals, which is affiliated with Akcea, and professor of medicine and director of vascular medicine at the University of California, San Diego, said in the release. “Recent data have shown that patients are particularly at risk when their Lp(a) levels go over 50 mg/dL. The data from this study are very encouraging as they show that AKCEA-APO(a)-L_Rx consistently reduced Lp(a) levels below this risk threshold. There are currently no treatment options available to patients that specifically target Lp(a). The introduction of a safe and effective therapeutic would represent a major advance in patient care.”

Disclosures: Soteropoulos is an employee of Akcea Therapeutics. Tsimikas reports he is an employee of and receives personal fees from Ionis Pharmaceuticals and is named as an inventor on patents held by University of California, San Diego, related to assessment of atherogenesis, risk prediction and therapy.