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Amgen And Cytokinetics Announce The First Presentation Of Data From Phase 2 ATOMIC-AHF Study Of Omecamtiv Mecarbil
Date:9/2/2013

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Sept. 3, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Cytokinetics Incorporated (NASDAQ: CYTK) today announced the first presentation of data from the ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) study at the ESC Congress 2013, organized by the European Society of Cardiology, in Amsterdam. ATOMIC-AHF was a randomized, double-blind, placebo-controlled Phase 2 study that enrolled 613 patients hospitalized with acute heart failure (AHF) treated for 48 hours with omecamtiv mecarbil or placebo and designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and potential efficacy of an intravenous formulation of omecamtiv mecarbil in patients with AHF. The study did not meet its primary endpoint of dyspnea (shortness of breath) response as measured by the 7-point Likert scale through 48 hours (p=0.33) but showed favorable dose and concentration-related trends on dyspnea response.

ATOMIC-AHF enrolled three, sequential, dose escalation cohorts of patients treated for 48 hours with omecamtiv mecarbil or placebo. The primary efficacy endpoint in ATOMIC-AHF was dyspnea symptom response. Secondary endpoints included other clinical and pharmacodynamic (echocardiographic) effects including death or worsening heart failure within seven days. The omecamtiv mecarbil treatment groups were not statistically different in their 7-point Likert scale dyspnea symptom response rates compared to the pooled placebo group (p=0.33); therefore, the primary endpoint was not met. Omecamtiv mecarbil demonstrated f
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