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.
METEORIC-HF – METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. This trial, to be conducted by Cytokinetics in collaboration with Amgen, is designed to enroll approximately 270 patients with HFrEF at sites throughout the U.S., Canada and Europe. Cytokinetics is working together with Amgen towards the objective of starting METEORIC-HF by the end of 2018.
Reldesemtiv has been the subject of five completed Phase 1 clinical trials in healthy volunteers evaluating its safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics.
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.
Reldesemtiv was the subject of a Phase 2 clinical trial designed to assess the potential effect of reldesemtiv compared to placebo on exercise tolerance, assessed as change from baseline in Constant Work Rate endurance time over two weeks, in approximately 40 patients with COPD. In October 2018, Cytokinetics and Astellas announced that the trial did not meet the primary endpoint and did not demonstrate a statistically significant treatment difference in any of secondary endpoints. Adverse events were similar between groups receiving reldesemtiv and placebo. For more information about the trial, click here.
Astellas also conducted a Phase 1b clinical trial designed to assess the effect of reldesemtiv versus placebo on skeletal muscle fatigue in approximately 60 subjects who are 70 to 89 years of age and who have limited mobility. In October 2018, Cytokinetics and Astellas announced that after an interim analysis of the study was conducted, the Independent Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met, and enrollment was halted. 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 completed enrollment in November 2018, having enrolled 458 patients with ALS in the US, Canada, Europe and Australia. The primary efficacy endpoint is the change from baseline in the percent predicted SVC at 12 weeks. Results are expected to be reported in the first half of 2019. For more information about the 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.