Amgen's olpasiran cuts cholesterol levels by 95% in heart disease patients in trial
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Amgen (NASDAQ:AMGN) said its drug olpasiran helped reduce a type of 'bad cholesterol' by more than 95% in patients with atherosclerotic cardiovascular disease (ASCVD) in a phase 2 trial.
The company presented end-of-treatment data from the study, dubbed OCEAN(a), initial results from which were reported in May. The trial, which enrolled 281 patients, evaluated different doses of olpasiran (formerly AMG 890) against placebo in patients with ASCVD and elevated Lipoprotein (Lp) (a) levels to reduce the risk of cardiovascular events.
Across groups, the median baseline Lp(a) concentration was 260.3 nmol/L. Lp (a) is a type of low-density lipoprotein (LDL), also called bad cholesterol, which contains a protein called apolipoprotein (a). Atherosclerosis is thickening of the arteries due to buildup of plaque in their inner lining.
Amgen said 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, according to the company.
Amgen added that the rates of adverse events were similar in the olpasiran and placebo groups.
The company noted that at week 36, Lp(a) increased by an average of 3.6% in the placebo arm, whereas there were substantial reductions of Lp(a) levels in all of the olpasiran groups.
"Our Phase 2 data for olpasiran presented at AHA continue to demonstrate a significant reduction in Lp(a) and provide strong evidence supporting its potential for patients with ASCVD," said David Reese, executive vice president of Research and Development at Amgen.
The company said it is starting a phase 3 cardiovascular Outcomes trial based on these results, wherein enrollment is expected to begin in December.