Over 50 clinical trials with a single focus:Improve lives
The safety, tolerability, pharmacokinetics, and pharmacodynamics of omecamtiv mecarbil have been studied across nine Phase 1 clinical trials, which enrolled over 200 healthy volunteers. In addition, four Phase 2 clinical trials have enrolled more than 1,300 people with heart failure.
Omecamtiv mecarbil is currently the subject of a Phase 3 clinical trials program. Recent trials include:
COSMIC-HF – Cytokinetics and Amgen announced results from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating oral omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, at the American Heart Association Scientific Sessions in November 2015. COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to evaluate the pharmacokinetics and tolerability of orally-administered omecamtiv mecarbil in approximately 450 patients.
ATOMIC-AHF – Cytokinetics and Amgen announced results from ATOMIC-AHF (A Trial of Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure), a Phase 2b trial evaluating omecamtiv mecarbil in acutely ill, hospitalized heart failure patients, at the European Society of Cardiology (ESC) Congress and the Heart Failure Society of America (HFSA) Annual Meeting, both in September 2013. This clinical trial was an international, multicenter, randomized, double-blind, placebo-controlled study in approximately 600 patients, enrolled in three sequential, ascending-dose cohorts. In each cohort, patients were randomized to receive omecamtiv mecarbil or placebo.
GALACTIC-HF – GALACTIC-HF is a Phase 3, double-blind, placebo-controlled, multicenter clinical trial to be conducted by Amgen in collaboration with Cytokinetics. The trial will evaluate the effect of treatment with omecamtiv mecarbil compared with placebo in approximately 8,000 subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy. The primary endpoint is time to cardiovascular death or first heart failure event, whichever comes first. GALACTIC-HF is being conducted under a Special Protocol Assessment (SPA) with the FDA. For more information about this trial, click here.
Tirasemtiv has been evaluated and characterized in a clinical program which included six Phase 2 trials and three Phase 1 trials, examining its safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics for the potential treatment of ALS, myasthenia gravis, and claudication. Tirasemtiv has been granted orphan drug designation and fast-track status by the U.S. Food and Drug Administration, as well as orphan medicinal product designation by the European Medicines Agency for the potential treatment of people with ALS. Recent trials include:
VITALITY-ALS – VITALITY-ALS is a multinational, randomized, double-blind, placebo-controlled trial that enrolled over 700 patients in 81 centers in 11 countries with possible, probable or definite ALS, diagnosed within 24 months, and with percent predicted slow vital capacity (SVC) at baseline ≥70%. SVC is a measure of the amount of air expelled from a patient’s lungs after inflation and is used to assess diaphragm strength. The primary endpoint of the trial will assess change from baseline in SVC after 24 weeks of treatment. Secondary endpoints, to be assessed at 48 weeks, include time to decline in any of the three respiratory domains of the ALSFRS-R or death; time to decline from baseline in percent predicted SVC by ≥20 percentage points or the onset of respiratory insufficiency or death; time to first occurrence of any use of assisted ventilation or death; time to decline from baseline in percent predicted SVC to ≤50% predicted or the onset of respiratory insufficiency or death; and change in the Mega-Score of muscle strength. VITALITY-ALS completed enrollment in August 2016, and results are expected in Q4 2017.
VIGOR-ALS – VIGOR-ALS is an open-label extension clinical trial of tirasemtiv in patients with ALS who completed participation in VITALITY-ALS. The primary endpoint of the trial is the incidence of adverse events in the patient population. Secondary endpoints include the time to events such as death or the first use of assisted ventilation or respiratory insufficiency; decline from baseline in percent predicted SVC, ALSFRS-R; and the slope of change from baseline in percent predicted SVC and ALSFRS-R. For more information about the trial, click here.
CK-2127107 (CK-107) has been the subject of five completed Phase 1 clinical trials in healthy volunteers evaluating its safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics. CK-107 is currently the subject of three Phase 2 clinical trials and one Phase 1b clinical trial.
In collaboration with Astellas, Cytokinetics is conducting a Phase 2 clinical trial designed to assess the effect of CK-107 on multiple measures of muscle function in both ambulatory and non-ambulatory patients with Type II, Type III, and Type IV SMA. For more information about the trial, click here.
Astellas is conducting a Phase 2 clinical trial in collaboration with Cytokinetics to evaluate the effect of CK-107 on physical function and exercise tolerance in patients with COPD. For more information about the trial, click here.
Astellas is also conducting a Phase 1b clinical trial in collaboration with Cytokinetics to evaluate the effect of CK-107 on measures of physical function in elderly adults with limited mobility. For more information about the trial, click here.
FORTITUDE-ALS – FORTITUDE-ALS is a Phase 2, double-blind, randomized, placebo-controlled, parallel group, dose ranging study of CK-107 in patients with ALS. The trial will enroll approximately 450 patients with ALS in the US and Canada. The primary efficacy endpoint is the change from baseline in the percent predicted SVC at 12 weeks. For more information about the trial, click here.