Date: 2016-12-01
Type of
information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Amgen (USA - CA) Cytokinetics (USA - CA) Servier (France)
Product: omecamtiv mecarbil
Action
mechanism:
- myosin activator. Omecamtiv mecarbil is a novel cardiac myosin activator. It activates cardiac muscle contractility and operates to strengthen heart function in patients with systolic dysfunction. 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 contractility in the absence of changes in intracellular calcium in cardiac myocytes.
- Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization rights. Servier has exercised an exclusive option granted by Amgen for the commercialisation of omecamtiv mecarbil in Europe , as well as the Commonwealth of Independent States, including Russia .
Disease: heart failure
Therapeutic
area: Cardiovascular diseases
Country: Australia, Belgium, Puerto Rico, Switzerland, USA
Trial
details:
- The purpose of the GALACTIC-HF study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF. (NCT02929329)
Latest
news:
- • On December 1, 2016, Cytokinetics announced the activation of the first clinical site and the start of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with Cytokinetics. Coincident with the start of the trial, Amgen will make a $26.7 million milestone payment to Cytokinetics.
- The primary objective of this double-blind, randomized, placebo-controlled multicenter clinical trial is to determine if treatment with omecamtiv mecarbil when added to standard of care is superior to standard of care plus placebo in reducing the risk of cardiovascular death or heart failure events in patients with high risk chronic heart failure and reduced ejection fraction.
- GALACTIC-HF will be conducted under a Special Protocol Assessment (SPA) with the FDA. The study is planned to enroll approximately 8,000 symptomatic chronic heart failure patients in over 800 sites in 34 countries who are either currently hospitalized for a primary reason of heart failure or have had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. In order to be eligible to participate in GALACTIC-HF patients should have an LVEF ? 35%, be NYHA class II to IV, and have an elevated BNP or NT-proBNP. Patients will be randomized to either placebo or omecamtiv mecarbil with dose titration up to a maximum dose of 50 mg twice daily based on the plasma concentration of omecamtiv mecarbil after initiation of drug therapy. The primary endpoint is a composite of time to cardiovascular death or first heart failure event, which is defined as either a hospitalization for heart failure or other urgent treatment for worsening heart failure. Secondary endpoints include time to cardiovascular death; patient reported outcomes as measured by the Kansas City Cardiomyopathy Questionnaire Total Symptom Score; time to first heart failure hospitalization; and all-cause death.
Is
general: Yes
