Amgen's heart drug reduces cardiovascular disease risk factor in phase 2 trial

Back in 2020, Amgen cast aside a cardiovascular disease hopeful from Cytokinetics and pointed the spotlight at a small interfering RNA treatment it thought could make up for the lost partnership. Now, in some limited phase 2 data, the pharma is making its case.

Olpasiran, previously known as AMG 890, has been found to reduce levels of lipoprotein, or Lp(a), which is a risk factor for cardiovascular disease. Research suggests that high levels of Lp(a) contributes to stroke, peripheral arterial disease and heart attack.

Amgen’s treatment was being tested in a phase 2 trial of 281 adults with elevated levels of Lp(a) and evidence of atherosclerotic cardiovascular disease. Olpasiran is designed to lower the production of a component of Lp(a).

Patients who received the therapy saw a reduction in baseline Lp(a) levels of up to or greater than 90% at week 36, which was the primary endpoint, and week 48, which was the end of treatment. Amgen noted that these data were for “a majority of doses” in the trial. The dose ranged from 10 mg to up to 225 mg every 12 weeks, but Amgen did not break out data for each individual dose.

No new safety concerns were identified in the trial, the company said. 

Amgen plans to present data from the study at an upcoming medical conference.

"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 Amgen’s David Reese, M.D., executive vice president of Research and Development. "We are very enthusiastic about these results and look forward to advancing olpasiran as a potential treatment for patients with elevated Lp(a)."

Amgen has been working on the study with its deCODE Genetics unit, which has been analyzing data to better narrow down the patient population for later trial phases. deCODE is examining protein levels in the blood to better predict who’s most at risk of cholesterol-related cardiovascular events.

Olpasiran came to the forefront in 2020 when Amgen canceled a partnership with Cytokinetics for the heart failure drug omecamtiv mecarbil after phase 3 data didn’t meet the pharma’s expectations. Reese at the time said that Amgen was still committed to cardiovascular disease despite walking away from the long-term partnership. He pointed to a phase 2 study of olpasiran as an example of that continued work.