POSITIVE TOP-LINE RESULTS FROM A PHASE 2 TRIAL OF OMECAMTIV MECARBIL IN PATIENTS WITH CHRONIC HEART FAILURE
Data Showed Statistically Significant Improvements in Several Pre-Specified Measures of Cardiac Function
Amgen (AMGN) and Cytokinetics (CYTK): Data from the expansion phase of COSMIC-HF – a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in several measures of cardiac function, including systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization.
The news that chronic heart failure patients badly need has come today at the hands of Cytokinetics and Amgen. Cytokinetics is the producer of the drug omecamtiv mecarbil and Amgen is the firm that knows well how to select and decide upon developing a drug that a few believed it would work.
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state.
Preclinical research has shown that cardiac myosin activators increase heart muscle contractility in the absence of changes in intracellular calcium in cardiac myocytes.
Amgen is developing Omecamtiv mecarbil in collaboration with Cytokinetics, which designed and produced the drug in the first place. Amgen holds an exclusive, worldwide license to drug and related compounds, subject to Cytokinetics’ specified development and commercialization rights. Additionally, Les Laboratoires Servierobtained an exclusive option to commercialize omecamtiv mecarbil in Europe.
Omecamtiv mecarbil is a novel drug. It enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of heart failure.
Data from The expansion phase of COSMIC-HF trial with omecamtiv mecarbil were positive It demonstrated that pharmacokinetic-based dose titration adequately controlled patient exposure to omecamtiv mecarbil and resulted in statistically significant decreases in cardiac dimensions and heart rate in the dose-titration group.
Adverse events: Here we believe there is good news stating that side effects, including serious adverse events in patients on omecamtiv mecarbil appeared comparable to those on placebo. Otherwise, there was a small increase in troponin with events that were independently adjudicated and none were determined to be myocardial ischemia or infarction. There was no imbalance in deaths, and cardiac adverse events were generally balanced between placebo and active treatment groups.
This news is refreshing. The study results will be submitted to a future medical conference and for publication.
What we read above is more than good news, as chronic heart failure was one of the life-threatening diseases whose treatments, safe and effective treatments have yet to reach the hands of cardiologists, and, consequently, strengthens the failed hearts.
This news made CYTK become attractive, as proof of concept of its technology and pipeline products would make investors look at this firm differently than looking at it while in development-stage, and its drugs had yet to come up with positive data.
Encouraging us to add this firm to our pipeline is that Heart failure affects more than 23 million people worldwide, half of whom have reduced left ventricular function. Also encouraging investing in CYTK is the fact that current standard treatments, although improved, the prognosis for patients with heart failure is still poor.
We wish the data from the late phase trials will confirm the successful outcome of this trial.
Our guess is that they will.
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