New England Journal of Medicine Publishes Results from Phase 2 Study of AKCEA-APO(a)-LRx in Patients with Lp(a)-driven Cardiovascular Disease

Patients treated with AKCEA-APO(a)-L_Rx received pre-specified endpoints for Lp(a) levels with favorable safety and tolerability profile

Global Lp(a)HORIZON Phase 3 cardiovascular outcomes study underway

BOSTON and CARLSBAD, Calif., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced that results from a Phase 2 study evaluating AKCEA-APO(a)-L_Rx, also known as TQJ230, in patients with established cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a), were published today in The New England Journal of Medicine (NEJM). The article is titled “Lipoprotein(a) Reduction in Persons with Cardiovascular Disease.” For the full text of this publication, please visit: www.NEJM.org.

Elevated Lp(a) is an independent, genetic risk factor for CVD that cannot be well controlled with lifestyle modifications such as diet or exercise or with treatment using existing lipid-lowering therapies. It is estimated that there are more than eight million patients living with CVD and elevated levels of Lp(a) worldwide. AKCEA-APO(a)-L_Rx was discovered by Ionis and co-developed through Phase 2 by Akcea and Ionis. It is an antisense medicine developed using Ionis’ advanced LICA technology designed to inhibit the production of apolipoprotein(a) and thus reduce Lp(a) levels.

“The Phase 2 study data show that we can get 98% of patients below 125 nmol/L (<50 mg/dL), the established threshold for a Lp(a)-driven CVD in people already on statin medications. The millions of people living with CVD and elevated Lp(a) are at risk of recurrent events such as myocardial infarction, stroke and peripheral arterial disease and currently have no effective pharmacological options that specifically target Lp(a),” said Dr. Sotirios Tsimikas, vice president of global cardiovascular development at Ionis Pharmaceuticals, professor of medicine and director of vascular medicine at the University of California San Diego and a principal author of the NEJM paper.  “We, along with the community of patients and physicians managing Lp(a), look forward to the Phase 3 clinical program that is now underway.”