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Amgen/Cytokinetics Drug Misses Primary Endpoint

Zacks Equity Research

Amgen (AMGN) 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 ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) study.

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 failure.

We note that omecamtiv mecarbil is being developed in collaboration with Cytokinetics (CYTK). Cytokinetics’ shares were down more than 26% on the data.

Both Amgen and Cytokinetics are Zacks Rank #3 (Hold) stocks. At present, companies like Biogen Idec (BIIB) and Gilead Sciences Inc. (GILD) look attractive with both being Zacks Rank #1 (Strong Buy) stocks.

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