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(RTTNews) – Amgen (AMGN) said that its phase 2 data for olpasiran continue to demonstrate a significant reduction in lipoprotein(a) and provide strong evidence supporting its potential for patients with atherosclerotic cardiovascular disease. It looks forward to studying this treatment further in Phase 3 clinical trials, which the company expects to begin enrolling in December 2022.
Epidemiological research has shown that lipoprotein(a) or Lp(a) is an independent risk factor and is primarily genetically determined. It has been estimated that up to 20% of people worldwide are living with elevated levels, which are linked to a higher risk for heart disease, stroke and the potential significant burden on patients with cardiovascular disease.
Amgen presented end-of-treatment data from its Phase 2 OCEAN(a)-DOSE study of investigational olpasiran (formerly AMG 890) in adults with elevated lipoprotein(a) [Lp(a)] levels (>150 nmol/L) and a history of atherosclerotic cardiovascular disease (ASCVD). The study was designed to assess safety, tolerability and optimal dose of olpasiran in adults with established ASCVD to reduce Lp(a).
OCEAN(a)-DOSE is a multicenter, randomized, double-blind, placebo-controlled dose-finding study of olpasiran in 281 patients with established ASCVD and Lp(a) levels >150 nmol/L. Patients were randomized to one of four doses of olpasiran (10 mg Q12 weeks, 75 mg Q12 weeks, 225 mg Q12 weeks or 225 mg Q24 weeks) or placebo, given subcutaneously.
Across cohorts, the median baseline Lp(a) concentration was 260.3 nmol/L. Patients who received 75 mg or higher every 12 weeks had a 95% or greater reduction in Lp(a) compared to placebo at week 36.
At these doses (75 mg or higher), more than 98% of patients achieved an Lp(a) level of 125 nmol/L or less at week 36.
Overall, the rates of adverse events were similar in the olpasiran and placebo arms. The most common treatment-related adverse events were injection site reactions, primarily pain.
At week 36, Lp(a) increased by a mean of 3.6% in the placebo arm, whereas there were substantial reductions of Lp(a) levels in all of the olpasiran arms. Placebo-adjusted mean percent reductions were 70.5% for 10 mg every 12 weeks, 97.4% for 75 mg every 12 weeks, 101.1% for 225 mg every 12 weeks and 100.5% for 225 mg every 24 weeks.
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