Date: 2017-08-02
Type of
information: Results
phase: 2
Announcement: results
Company: Cytokinetics (USA - CA)
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 for the potential treatment of heart failure. 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: Japan
Trial
details:
- This Phase 2 clinical trial in Japanese patients with heart failure was designed to assess the pharmacokinetics of omecamtiv mecarbil as well as its effect on cardiac function, safety and tolerability in Japanese patients with chronic heart failure. The trial randomized 81 patients 1:1:1:1 to placebo, 25 mg of omecamtiv mecarbil twice daily and two separate PK-based titration groups in which the dose of omecamtiv mecarbil could be increased from 25 to 37.5 mg or 50 mg twice daily based on the pre-dose concentration of omecamtiv mecarbil at week 2. Patients received study drug for 16 weeks after randomization. The primary endpoint was to assess the plasma concentrations of omecamtiv mecarbil at weeks 2, 4, 12 and 16, and the area under the curve (AUC) at week 8. The secondary endpoint was to assess the change from baseline in SET measured by echocardiography at week 16.
Latest
news:
- • On August 2, 2017, Cytokinetics announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time, a secondary endpoint.
- Cytokinetics is eligible to earn a $10 million milestone payment from Amgen upon the first dosing of a patient in Japan in GALACTIC-HF, the ongoing Phase 3 cardiovascular clinical outcomes trial of omecamtiv mecarbil.
Is
general: Yes
