A little more than two years ago Amgen ($AMGN) and its partner Cytokinetics ($CYTK) were hit by a backlash as their IV version of the heart drug omecamtiv mecarbil failed a key Phase IIb trial for heart disease. A follow-up study of an oral version of the drug, though, proved positive, the partners announced over the weekend, opening up a potential path forward into late-stage studies.
The drug activates cardiac myosin, amping up the heart's ability to contract. The key secondary endpoints in the study were focused on systolic ejection time, stroke volume and heart rate, with improvements clustering in the 50-mg dose group. A total of 448 patients were evaluated in the expansion phase of the Phase II study.
The adverse event profiles were similar between the drug and placebo arms, investigators reported. And San Francisco-based Cytokinetics' shares were buoyed by the results, up about 5% on Monday morning.
The data were presented at the American Heart Association's Scientific Sessions 2015 in Orlando.
|Cytokinetics CEO Robert Blum|
The data positions omecamtiv as a player to watch in Amgen's cardio pipeline, though it still has a very long way to go. Regulators require big Phase III trials and set the safety bar high on new drugs for heart failure. The big biotech scored a major advance with the approval of its PCSK9 blockbuster drug Repatha. It's expected to hit much more modest sales goals with the newly approved Corlanor, which has been relegated to the margins by many analysts.
"Data from COSMIC-HF highlight the potential of cardiac myosin activation for the treatment of heart failure patients," said Robert Blum, president and CEO at Cytokinetics. "It's particularly gratifying to see the consistency of effect with chronic omecamtiv mecarbil therapy across important echocardiographic measures of cardiac function."
- here's the release