May 18, 2021
When omecamtiv mecarbil is used in patients who have chronic heart failure with reduced ejection fraction (HFrEF), the greater beneficial impact on clinical outcomes is seen in those with lower ejection fractions, a secondary analysis of the placebo-controlled GALACTIC-HF trial shows.
Among the prespecified subgroups in the trial, LVEF was the strongest modifier of the treatment effect, with larger reductions in the risk of HF events or CV death observed as values fell (
P = 0.004 for interaction). Reductions in NT-proBNP were greater at the lower end of the range, as well, John Teerlink, MD (San Francisco VA Medical Center and the University of California, San Francisco), reported during the recent virtual American College of Cardiology (ACC) 2021 Scientific Session.
Operator
Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics First Quarter 2021 Conference Call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company s request, we will open the call for questions-and-answers after the presentation.
I will now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.
Diane Weiser
Senior Vice President of Corporate Communications & Investor Relations
Good afternoon, and thanks for joining us on the call today. Robert Blum, our President and Chief Executive Officer, will kick off the call with an overview of the quarter and recent developments. Then Fady Malik, our EVP of Research and Development, will provide an update on omecamtiv mecarbil, including progress following a recent meeting with FDA and what to expect from upcoming analyses from GALACTIC-H
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Cardiol Therapeutics Inc.: Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19
Oakville, Ontario (Newsfile Corp. - January 21, 2021) - Cardiol Therapeutics Inc. (
Cardiol or the
Company ), a clinical-stage biotechnology company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease, today announced the formation of the Data Safety Monitoring Committee ( DSMC ) and the Clinical Endpoint Committee ( CEC ) for the Company s Phase II/III trial in high-risk patients hospitalized with COVID-19 at clinical centers throughout the United States.
The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial. In order to do so, the DSMC may review unblinded study information (on a patient level or treatment group lev