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AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 2 DATA FOR INVESTIGATIONAL OLPASIRAN IN ADULTS WITH ELEVATED LIPOPROTEIN(a)
Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period Lipoprotein(a) Reduction was Consistent With Phase 1 Results THOUSAND
About this update from Amgen Inc.
[{"type":"text","content":"Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period \nLipoprotein(a) Reduction was Consistent With Phase 1 Results \nTHOUSAND OAKS, Calif., May 31, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline data from the Phase 2 OCEAN(a)-DOSE clinical study, evaluating olpasiran (formerly AMG 890) in 281 adult patients with Lipoprotein(a), or Lp(a), levels over 150 nmol/L and evidence of atherosclerotic cardiovascular disease (ASCVD). Olpasiran is a small interfering RNA designed to lower the body's production of apolipoprotein(a), a key component of Lp(a) that has been associated with an increased risk of cardiovascular events. \nIn the double-blind placebo-controlled treatment period, olpasiran was administered up to 225 mg subcutaneously every 12 weeks to patients with a median baseline Lp(a) of approximately 260 nmol/L. These data demonstrated a significant reduction from baseline in Lp(a) of up to or greater than 90 percent at week 36 (primary endpoint) and week 48 (end of treatment period) for the majority of doses. No new safety concerns were identified during this treatment period.\n\"Lp(a) has remained an elusive target since it was first discovered almost 60 years ago because diet and exercise have minimal influence on Lp(a) levels as do currently available medicines, leaving patients with limited options,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We are very enthusiastic about these results and look forward to advancing olpasiran as a potential treatment for patients with elevated Lp(a).\"\nData from the Phase 2 study will be presented at a future medical congress and submitted for publication. \nAbout Lp(a)Lp(a) is genetically determined1,2 and reported to be an independent risk factor for cardiovascular disease (CVD). Although an agreed upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).3 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease .2\nAbout OCEAN(a) The OCEAN(a) (Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction) clinical program for Amgen's investig...