) recently presented data on its cardiovascular candidate,
omecamtiv mecarbil, at the European Society of Cardiology. Amgen
said that omecamtiv mecarbil failed to meet its primary endpoint
in the randomized, double-blind, placebo-controlled phase II
The study (n=613), conducted in patients hospitalized with
acute heart failure (AHF), evaluated the safety,
pharmacokinetics, pharmacodynamics, and efficacy of an
intravenous formulation of omecamtiv mecarbil. Patients were
treated in three, sequential, dose escalation cohorts of
omecamtiv mecarbil or placebo for 48 hours.
Omecamtiv mecarbil missed the primary endpoint of dyspnea
(shortness of breath) response (measured by the 7-point Likert
scale) through 48 hours. However, favorable dose and
concentration-related trends on dyspnea response were observed.
Moreover, the incidence of worsening heart failure within seven
days of the commencement of treatment was 17% in the pooled
placebo group and 13%, 8% and 9% on omecamtiv mecarbil in the
first, second and third cohorts, respectively.
Heart rate or blood pressure was not adversely affected in
patients on omecamtiv mecarbil. Omecamtiv mecarbil was also not
associated with an increased incidence of tachyarrhythmias.
Amgen intends to wait for data from the COSMIC-HF study before
deciding whether omecamtiv mecarbil should be moved into phase
III development. Although omecamtiv mecarbil missed the primary
endpoint, other data points from the study were encouraging
especially the data related to the incidence of worsening heart
We note that omecamtiv mecarbil is being developed in
). Cytokinetics' shares were down more than 26% on the data.
Both Amgen and Cytokinetics are Zacks Rank #3 (Hold) stocks.
At present, companies like
Gilead Sciences Inc.
) look attractive with both being Zacks Rank #1 (Strong Buy)
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