"Cytokinetics, Incorporated (CYTK) announced today the opening to enrollment of a Phase II clinical trial of oral formulations of omecamtiv mecarbil. This trial, known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), is sponsored by Amgen in collaboration with Cytokinetics and is designed to evaluate the safety and efficacy of a novel cardiac muscle myosin activator, omecamtiv mecarbil, in patients with heart failure and left ventricular systolic dysfunction.
"We are pleased that this international Phase II clinical trial designed to evaluate several oral formulations of omecamtiv mecarbil is now open to enrollment," stated Andrew A. Wolff, MD, FACC, Cytokinetics` Senior Vice President of Clinical Research and Development and Chief Medical Officer. "The objective of this trial is to identify and characterize an oral modified-release formulation of omecamtiv mecarbil that may progress into the Phase III clinical program. The data from COSMIC-HF, in combination with the data from the ongoing ATOMIC-AHF clinical trial evaluating an intravenous formulation of omecamtiv mecarbil, will contribute to the design of a potential registration program for this drug candidate."
Amgen holds an exclusive, worldwide license (excluding Japan) to omecamtiv mecarbil and related compounds, subject to specified development and commercialization participation rights of Cytokinetics.
COSMIC-HF: Phase II Clinical Trial of Omecamtiv Mecarbil:
OSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to select and evaluate an oral modified-release formulation of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. During the dose escalation phase, approximately 40 patients will be randomized 1:1:1:1 to placebo or one of three different oral formulations of omecamtiv mecarbil in each of two ascending dose pharmacokinetic (PK) cohorts to enable selection of one of these oral formulations for the planned expansion phase of the trial. The dose of omecamtiv mecarbil will be 25 mg twice daily in the first PK cohort and 50 mg twice daily in the second PK cohort. Following the dose escalation phase of the trial, there is a planned expansion phase of the trial in which approximately 300 patients will be randomized 1:1:1 to receive one oral formulation of omecamtiv mecarbil selected from the three studied in the prior ascending dose PK cohorts at one of two dose levels or placebo. The two dose levels of omecamtiv mecarbil to be studied in the expansion cohort will be based on the data from the ascending dose PK cohorts. The primary objectives of this study are to select an oral modified-release formulation and dose of omecamtiv mecarbil for chronic twice daily dosing in patients with heart failure and left ventricular systolic dysfunction and to characterize its safety, tolerability, and pharmacokinetics after 12 weeks of treatment. The secondary objectives are to #$%$ the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) after 12 weeks of treatment.
ATOMIC-AHF: Phase IIb Clinical Trial of Intravenous Omecamtiv Mecarbil
ATOMIC-AHF is an ongoing Phase IIb clinical trial designed to evaluate an intravenous formulation of omecamtiv mecarbil in approximately 600 patients enrolled in 3 sequential, ascending-dose cohorts. In each cohort, patients will be randomized 1:1 to omecamtiv mecarbil or placebo. The primary objective of this trial is to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to placebo on dyspnea (shortness of breath) in patients with left ventricular systolic dysfunction hospitalized for acute heart failure. The secondary objectives are to #$%$ 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 #$%$ments, change in N-terminal pro brain-type natriuretic peptide and short-term clinical outcomes in these patients. In addition, the trial is evaluating the relationship between omecamtiv mecarbil plasma concentrations and these parameters in patients with acute heart failure.
Development Status of Omecamtiv Mecarbil
In 2012, Cytokinetics and Amgen reviewed data from a prior Phase I randomized, open-label, 4-period cross-over clinical trial designed to #$%$ the safety, tolerability and pharmacokinetics of multiple oral formulations of omecamtiv mecarbil in healthy volunteers. The formulations to be evaluated in COSMIC-HF were selected from among those oral formulations.
Prior to the conduct of the ATOMIC-AHF Phase IIb and COSMIC-HF Phase II clinical trials, omecamtiv mecarbil was the subject of a clinical trials program conducted by Cytokinetics comprised of five Phase I trials in healthy volunteers and two Phase IIa trials in patients with heart failure. Those trials were designed to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of both intravenous and oral formulations of omecamtiv mecarbil for the potential treatment of heart failure. Data from each of these trials were reported previously."
IMHO, this is a great time to invest in this company....Good things to come.....Patience!!