Press release
AMGEN PRESENTS LATE-BREAKING PHASE 2 OLPASIRAN DATA AT ESC 2023
Amgen is Changing the Cardiovascular Disease Treatment Landscape With New Research on Innovative Lipid Management New Olpasiran Phase 2 Data Demonstrates
About this update from Amgen Inc.
[{"type":"text","content":"Amgen is Changing the Cardiovascular Disease Treatment Landscape With New Research on Innovative Lipid Management \nNew Olpasiran Phase 2 Data Demonstrates Continued Reduction of Lp(a) Nearly a Year After the Last Dose\nAmgen Convenes First LDL Awareness to Action Implementation Consortium \nTHOUSAND OAKS, Calif., Aug. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced data from the final analysis of the Phase 2 OCEAN(a)-DOSE study of olpasiran, a small interfering RNA (siRNA) during the Late-Breaking Science Session at the European Society of Cardiology (ESC) Annual Meeting being held in Amsterdam. In the off-treatment extension period, olpasiran showed a lasting effect on Lp(a) reduction nearly a year after the last dose.\nResults from the OCEAN(a)-DOSE Phase 2 study announced in November of 2022 showed that doses of olpasiran ≥75 mg Q12W reduced patients' Lp(a) by >95% at week 36. The results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose. No new safety concerns were identified during the off-treatment extension period.\n\"We are dedicated to reducing LDL cholesterol levels in people globally and continuing to pioneer ways to address the greatest risk factors in cardiovascular disease, including Lp(a). Worldwide, millions of people are at an increased risk of cardiovascular events due to elevated Lp(a) levels. Unfortunately, there are no approved medicines,\" said Paul Burton, senior vice president and chief medical officer at Amgen. \"Data from the off-treatment extension period provide additional evidence of olpasiran's lasting effect in reducing Lp(a) levels. We are quickly advancing the Phase 3 cardiovascular outcome trial.\"\nAdditionally, this study was the first to explore the effects of olpasiran on a key biomarker strongly associated with atherosclerosis, pro-atherogenic OxPL-apoB [Oxidized Phospholipids (Ox-PL) on apoB-100 (apoB)]. During the treatment period, olpasiran showed a dose-dependent reduction in pro-atherogenic OxPL-apoB.\n\"Additional results from the OCEAN(a)-DOSE study continue to be encouraging, as they tell us olpasiran not only robustly reduces Lp(a) levels, but that it has a long-lasting effect on this important risk factor for ASCVD,\" sa...