Interleukin Genetics Inc, Waltham, Mass, has entered into an agreement with Isis Pharmaceuticals Inc, Carlsbad, Calif, to provide genetic testing services for Isis’s Phase 2 clinical study evaluating its novel therapeutic, Isis-APO(a)Rx, in patients with high lipoprotein(a) levels (Lp(a)), an independent risk factor for cardiovascular disease.

Patients with high levels of Lp(a) have an increased risk of atherosclerosis, coronary heart disease, aortic stenosis, heart attack, and stroke. Isis-APO(a)Rx is designed to reduce Lp(a) by inhibiting production of the apolipoprotein(a) component of Lp(a). Isis is developing Isis-APO(a)Rx to treat patients with high Lp(a) levels who are at high risk of experiencing life-threatening cardiovascular events.

Lp(a) is a lipoprotein particle that is assembled in the liver and consists of an LDL-C-like particle and apolipoprotein(a). Lp(a) levels in blood can vary greatly between individuals due primarily to genetic variations in the gene that encodes for apolipoprotein(a). Lp(a) levels are genetically determined and remain constant throughout the life of the individual. As a result, diet and lifestyle changes have little impact on Lp(a) levels, and current therapies are not able to adequately reduce elevated levels of Lp(a) to recommended levels in patients who have high Lp(a) levels.

Kornman

Kenneth S. Kornman, DDS, PhD

“We look forward to working with Isis and the study investigators, using our current genetic test panels for inflammatory and metabolic diseases to explore genetic factors that may add value in this clinical trial,” says Kenneth S. Kornman, DDS, PhD, CEO of Interleukin. “Recent work has shown that the combination of elevated Lp(a) levels in patients who overproduce interleukin-1 was a strong predictor of secondary cardiovascular events.1 In this study, we were able to identify patients with elevated Lp(a) levels who also overproduced interleukin-1 using our Interleukin Genetics test. This is a prime example of how Interleukin Genetics works with pharmaceutical companies to employ complementary genetic tests designed to improve clinical outcomes.”

Interleukin Genetics is leveraging its expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The company’s lead products include its proprietary PerioPredict genetic risk panel for periodontal disease and tooth loss susceptibility, available through dentists, and the Inherent Health Weight Management genetic test that identifies the most effective diet program for an individual based on genetics. For additional information, visit Interleukin Genetics.

According to Isis, the Phase 2 study is a randomized, placebo-controlled, dose-titration study evaluating the safety and efficacy of Isis-APO(a)Rx. The 12-week study will evaluate 100 mg, 200 mg, and 300 mg doses of IsisS-APO(a)Rx in approximately 60 patients with Lp(a) levels of 50 mg/dL or greater. According to the National Institutes of Health, an average normal Lp(a) level is less than 30 mg/dL, and the European Atherosclerosis Society recommends that Lp(a) levels be less than or equal to 50 mg/dL.

For more information about the ongoing Isis clinical study, visit the National Institutes of Health ClinicalTrials.gov website.

REFERENCE

Tsimikas S, Duff GW, Berger PB, et al. Risk of coronary artery disease and cardiovascular events mediated by oxidized phospholipids and lipoprotein(a). J Am Coll Cardiol. 2014;63(17):1724–1734; doi:10.1016/j.jacc.2013.12.030.