Patients who took the treatment didn’t experience any improvement in dyspnea, or shortness of breath, compared to those who got a placebo, researchers said today at the European Society of Cardiology’s conference in Amsterdam. The study compared three different dosage levels with a placebo. Researchers said the group that got the highest dose showed a trend toward improvement.
Called Atomic-AHF, the study is the first of two trials that Thousand Oaks, California-based Amgen has said it will use to decide whether to move the drug into the final and most expensive stage of patient testing. Amgen bought the rights to South San Francisco-based Cytokinetics leading product candidate in 2009.
“I would be discouraged by the results of this” from thinking the drug has an important effect for patients, said Christopher Granger, director of the Cardiac Care Unit at Durham, North Carolina-based Duke University, who wasn’t involved with the study. There’s no obvious reason to think the second trial will succeed if this one didn’t, Granger said.
Amgen will wait for data from the second trial, Cosmic-HF, which tests an oral version of the drug in patients with chronic heart failure, before deciding whether to keep working on the project, Sean Harper, executive vice president of research and development, said in a statement. Today’s study, where patients hospitalized with acute heart failure were treated for 48 hours, tested an intravenous version.
Amgen is pursuing a second trial because the two studies look at different patient groups and different treatment regimens with different goals, the company said in an e-mailed statement. “Amgen considers these two trials to answer unique and complementary questions,” the company said.
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