Cytokinetics (CYTK) ATOMIC-AHF Results to Be Presented at ESC Congress 2013 (AMGN)
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Cytokinetics Incorporated (Nasdaq: CYTK) announced that results from ATOMIC-AHF have been accepted for presentation during a Hot Line Late Breaking Trials Session at the European Society of Cardiology (ESC) Congress 2013. ATOMIC-AHF is a Phase IIb clinical trial designed to evaluate the safety, tolerability and efficacy of an intravenous formulation of omecamtiv mecarbil compared to placebo in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure.
Amgen (Nasdaq: AMGN) holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization participation rights. ATOMIC-AHF was conducted by Amgen in collaboration with Cytokinetics. Cytokinetics is reviewing initial data from ATOMIC-AHF with Amgen. The ESC policy with regard to clinical trial results accepted for presentation at its Congress is that no results should be disclosed publicly until presented at the Congress or as may otherwise be approved in advance by the ESC. Cytokinetics does not have current plans to disclose results from ATOMIC-AHF prior to the ESC Congress 2013.
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) is a recently completed Phase IIb clinical trial which was designed to evaluate an intravenous formulation of omecamtiv mecarbil in approximately 600 patients hospitalized with acutely decompensated heart failure enrolled in 3 sequential, ascending-dose cohorts. The primary efficacy objective of this trial was to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to placebo on dyspnea (shortness of breath) in this patient population. The secondary objectives were to assess the safety and tolerability of 3 dose levels of intravenous omecamtiv mecarbil compared with placebo and to evaluate the effects of 48 hours of treatment with intravenous omecamtiv mecarbil on additional measures of dyspnea, patients’ global assessments, change in N-terminal pro brain-type natriuretic peptide (a biomarker associated with the severity of heart failure) and short-term clinical outcomes in these patients. In addition, the trial was designed to evaluate the relationship between plasma concentrations of omecamtiv mecarbil and several pharmacodynamic parameters, including echocardiographic indices of left ventricular function, in patients with acutely decompensated heart failure.
Amgen (Nasdaq: AMGN) holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization participation rights. ATOMIC-AHF was conducted by Amgen in collaboration with Cytokinetics. Cytokinetics is reviewing initial data from ATOMIC-AHF with Amgen. The ESC policy with regard to clinical trial results accepted for presentation at its Congress is that no results should be disclosed publicly until presented at the Congress or as may otherwise be approved in advance by the ESC. Cytokinetics does not have current plans to disclose results from ATOMIC-AHF prior to the ESC Congress 2013.
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) is a recently completed Phase IIb clinical trial which was designed to evaluate an intravenous formulation of omecamtiv mecarbil in approximately 600 patients hospitalized with acutely decompensated heart failure enrolled in 3 sequential, ascending-dose cohorts. The primary efficacy objective of this trial was to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to placebo on dyspnea (shortness of breath) in this patient population. The secondary objectives were to assess the safety and tolerability of 3 dose levels of intravenous omecamtiv mecarbil compared with placebo and to evaluate the effects of 48 hours of treatment with intravenous omecamtiv mecarbil on additional measures of dyspnea, patients’ global assessments, change in N-terminal pro brain-type natriuretic peptide (a biomarker associated with the severity of heart failure) and short-term clinical outcomes in these patients. In addition, the trial was designed to evaluate the relationship between plasma concentrations of omecamtiv mecarbil and several pharmacodynamic parameters, including echocardiographic indices of left ventricular function, in patients with acutely decompensated heart failure.
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