After more than a decade working on heart failure programs with Cytokinetics, Amgen is handing two programs back to its partner. The move comes after their more advanced program beat placebo in a phase 3 study at warding off hospitalizations and other interventions in patients with a type of chronic heart failure—but did not help them live longer.
The Big Biotech is returning the rights to the drug, omecamtiv mecarbil, along with those to an earlier-stage asset, AMG 594, to Cytokinetics, it said in a statement on Monday. The duo first teamed up to develop new medicines for heart failure in 2006, with Amgen licensing omecamtiv mecarbil in 2009. In 2013, Amgen added Japan to its license and French pharma Servier picked up the European rights to the drug.
The duo unveiled topline data from the phase 3 GALACTIC-HF study in October, following up with full data at the virtual meeting of the American Heart Association earlier this month. The study tested omecamtiv mecarbil against placebo in more than 8,200 patients who had heart failure with reduced ejection fraction (HFrEF). In this type of heart failure, the heart muscle does not contract effectively, so less oxygen-rich blood gets pumped out to the body.
On paper, the study succeeded. It met its primary endpoint, reducing the amount of time until patients either died from heart-related causes or needed treatment for heart failure by 8%. However, the drug did not move the needle on the study’s secondary endpoints, namely time to first hospitalization, death from heart-related causes, death from any cause, and change from baseline on a questionnaire that measures how patients perceive their health status.
“The lack of effect on death from either cardiovascular causes or any cause is surprising, given the prior evidence with omecamtiv mecarbil of improvements in left ventricular volumes and function, as well as decreases in heart rate and NT-proBNP,” a hormone linked to worsening heart failure, the investigators wrote in their study, which appeared in the New England Journal of Medicine.
The data were “underwhelming” and a “GALACTIC Disappointment,” JPMorgan analyst Cory Kasimov wrote in a note to clients when Amgen reported the topline data. Not helping patients live longer “casts doubt on the outlook of this product candidate,” he wrote at the time.
Now, having washed its hands of omecamtiv mecarbil, Amgen is turning to other programs in its cardiovascular stable, including olpasiran, also known as AMG 890, a small interfering RNA (siRNA) treatment in development for atherosclerotic heart disease.
"Cardiovascular disease is one of the most significant public health issues in the world which means patients need more innovation, not less. Our commitment to cardiovascular disease remains steadfast, and we look forward to continuing to work closely with the cardiovascular community as we focus on advancing our innovative therapies, including our Lp(a) inhibitor olpasiran (AMG 890), which is currently in Phase 2," said Amgen R&D chief David Reese, M.D., in the statement. "We are grateful to the investigators and patients who participated in GALACTIC-HF. Unfortunately, the results of GALACTIC-HF did not meet the high bar we had set for the program."