Heart-to-Heart or Head-to-Head: Amgen Heart Drug to Challenge Novartis
Amgen has published data from their phase II study into the investigational drug olpasiran which shows that the drug has a promising capacity to reduce levels of lipoprotein (Lp(a)), a risk factor for cardiovascular disease. The results set up olpasiran as a potential challenger to Novartis’ pelacarsen, which is already in phase III trials.
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Lp(a) has been established as an independent risk factor that is primarily genetically determined. David M. Reese, executive vice president of R&D at Amgen, stated that “it has been estimated that up to 20% of people worldwide are living with elevated levels [of Lp(a)], which are linked to a higher risk for heart disease, stroke and the potential significant burden on patients with cardiovascular disease.”
Olpasiran is an interfering RNA treatment, previously called AMG 890, which Amgen acquired in 2020 from Arrowhead Pharmaceuticals. The data released this week came from the phase II OCEAN(a)-DOSE study, a “multicentre, randomised, double-blind, placebo-controlled dose-finding study” designed to assess safety, tolerability, and optimal dosage. 281 adults with elevated levels of Lp(a) (> 150 nmol/L) and a history of atherosclerotic cardiovascular disease (ASCVD) were randomly allocated one of four doses of olpasiran ranging from 10mg every 12 weeks to 225mg every 24.
The findings set Amgen apart from others in the market since there are currently no approved therapies which can consistently and significantly reduce Lp(a) concentration.
At the three-month mark, the study found that olpasiran reduced Lp(a) levels by over 95% for patients receiving 75mg or more compared to placebo. Moreover, dosages above 75mg resulted in an Lp(a) level below 125 nmol/L in over 98% of participants. By contrast, at the same time point, lipoprotein levels had increased by 3.6% on average in the placebo arm of the study.
The findings set Amgen apart from others in the market since there are currently no approved therapies which can consistently and significantly reduce Lp(a) concentration. Novartis’ competitor, pelacarsen, a phase III antisense/GalNAc, has only shown a 72% reduction in Lp(a) with a 60mg monthly dosage. Their phase III trial, which has 8,325 participants with a history of cardiovascular disease, is due to end in May 2025, putting them ahead of Amgen but not too substantially.
Amgen now intends to launch their own phase III pivotal trial for olpasiran. They plan to begin the trial as early as December 2022 with 6,000 cardiovascular patients, with an estimated completion date of December 2026. The phase III trial will examine the time to death from coronary heart disease, urgent coronary revascularisation, or myocardial infarction, whilst also continuing to assess the longevity of the drug’s efficacy.
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