Treatment wth olpasiran, a small interfering RNA product targeting lipoprotein (a) synthesis, led to a profound and sustained reduction in Lp(a) concentration when administered every 12 weeks in a new phase 2 study.
The OCEAN(a)-DOSE study showed that doses of 75 mg or more of olpasiran every 12 weeks led to reductions of more than 95% in levels of Lp(a) in individuals with high serum Lp(a) levels at baseline and a history of atherosclerotic cardiovascular disease.
In terms of safety, the overall incidence of adverse events was similar to placebo, with the most common olpasiran-related adverse events being injection site reactions, primarily pain, but these were described as mild in severity and resolved without treatment.
The study findings were presented November 6 at the American Heart Association (AHA) Scientific Sessions 2022 by Michelle O'Donoghue, MD, MPH, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
They were also simultaneously published online in The New England Journal of Medicine.
"These findings set the foundation for phase 3 testing scheduled to commence later this year," O'Donoghue concluded.
Amgen, the drug's manufacturer, has not yet announced the dose that will be used in the phase 3 trials.
"Here we have evidence that a small interfering RNA product truly leads to a marked and sustained reduction in Lp(a) levels, with effects that persist over 12 weeks," O'Donoghue told
