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 was a multi-national, randomized, double-blind, placebo-controlled trial in patients with possible, probable or definite ALS, diagnosed within 24 months, and with SVC at baseline ≥ 70 percent predicted. VITALITY-ALS did not meet the primary endpoint of change from baseline in slow vital capacity (SVC) which was evaluated at 24 weeks following randomization or any of the secondary endpoints in the trial which were evaluated at 48 weeks. No new safety or tolerability findings related to tirasemtiv were identified in VITALITY-ALS. Serious adverse events were similar between patients who received tirasemtiv or placebo but more patients discontinued double-blind treatment on tirasemtiv than on placebo primarily due to non-serious adverse events related to tolerability.
VIGOR-ALS – VIGOR-ALS is an open-label extension clinical trial of tirasemtiv in patients with ALS who completed participation in VITALITY-ALS. Cytokinetics will seek advice from the academic leadership of VITALITY-ALS and its clinical investigators, regulatory authorities and other consultants before making decisions about continuing treatment with tirasemtiv in VIGOR-ALS.
Reldesemtiv has been the subject of five completed Phase 1 clinical trials in healthy volunteers evaluating its safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics. Reldesemtiv is currently the subject of two Phase 2 clinical trials and one Phase 1b clinical trial.
Cytokinetics and Astellas announced results from a hypothesis-generating Phase 2 clinical study of reldesemtiv in 70 patients with Type II, Type III and Type IV spinal muscular atrophy (SMA) at the Annual Cure SMA Conference in June 2018. The study showed dose- and concentration-dependent increases in time to muscle fatigue as measured by changes from baseline in Six Minute Walk Distance (6MWD), a sub-maximal exercise test of aerobic capacity and endurance, and Maximal Expiratory Pressure (MEP), a measure of strength of respiratory muscles, after eight weeks of treatment with reldesemtiv. Adverse events were similar between groups receiving reldesemtiv and placebo. 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 reldesemtiv 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 reldesemtiv 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 reldesemtiv 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.