Amgen's RNAi Therapy Olpasiran Achieves Over 90% Reduction in Lipoprotein(a) in Phase II Trial

On May 31, Amgen announced positive key results for olpasiran in the Phase II OCEAN(a)-DOSE study targeting elevated lipoprotein(a).

Lipoprotein(a) is genetically regulated and produced in the liver, and has been reported as an independent risk factor for cardiovascular disease. Pathophysiological, epidemiological, and genetic studies suggest that elevated Lp(a) plays a potential role in myocardial infarction, stroke, and peripheral artery disease. Although there is currently no clear threshold defined for abnormally high lipoprotein(a), approximately 20% of adults have Lp(a) levels exceeding 125 nmol/L (approximately 50 mg/dL).

Lipoprotein(a) consists of low-density lipoprotein (LDL-C)-like particles and apolipoprotein(a). Olpasiran is a small interfering RNA (siRNA) that reduces the production of apolipoprotein(a) in the body, thereby lowering lipoprotein(a) levels.

OCEAN(a)-DOSE Study Included 281 Patients with Lipoprotein(a) Levels Over 150 nmol/L (Median Level 260 nmol/L) and Symptoms of Atherosclerotic Cardiovascular Disease (ASCVD). Patients Were Administered Subcutaneous Injections of Olpasiran at Doses of 10 mg, 75 mg, or 225 mg Every 12 Weeks, 225 mg Every 24 Weeks, or Placebo. The Primary Endpoint Was the Change in Lipoprotein(a) from Baseline at Week 36. The Secondary Endpoint Was the Change in Lipoprotein(a) from Baseline at Week 48.

Results showed that patients' lipoprotein(a) levels decreased by more than 90% at weeks 36 and 48, with consistent effects observed across multiple doses. No new safety events were identified during the treatment period.

Note: The original text has been abridged.