Cytokinetics, Incorporated Announces Results from Four Clinical Trials of Ck-2127107 Expected in 2018
January 03, 2018 at 06:00 pm IST
Share
Cytokinetics, Incorporated announced results from four trials expected in 2018 under collaboration with Astellas. CK-2127107 is the subject of four mid-stage clinical trials enrolling patients in both neuromuscular and non-neuromuscular diseases or conditions in which impaired muscle function and weakness play a meaningful role. These include Phase 2 clinical trials in patients with spinal muscular atrophy (SMA), chronic obstructive pulmonary disease (COPD) and amyotrophic lateral sclerosis (ALS) and a Phase 1b clinical trial in elderly adults with limited mobility or frailty. Cytokinetics is conducting a Phase 2 double-blind, randomized, placebo-controlled clinical trial in patients with SMA which is designed to determine potential pharmacodynamic effects of a suspension formulation of CK-2127107 following 8 weeks of oral dosing in each of two cohorts of 36 patients with Type II, Type III, or Type IV disease. Secondary objectives are to evaluate the safety, tolerability and pharmacokinetics of CK-2127107. There is no single primary endpoint in this hypothesis-generating trial. Multiple assessments of skeletal muscle function and fatigability are being performed, including respiratory assessments, upper limb strength and functionality for non-ambulatory patients, as well as six-minute walk and timed-up-and-go for ambulatory patients. Patients enrolled in the second cohort will also be assessed with the SMA Health Index, a patient reported outcome measure. Astellas is conducting a Phase 2 clinical trial which is designed to assess the effect of CK-2127107 compared to placebo on exercise tolerance in approximately 40 patients with COPD. Additionally, the trial will assess cardiopulmonary and neuromuscular effects of CK-2127107 relative to placebo and the effect of CK-2127107 on resting spirometry relative to placebo. In addition, the safety, tolerability and pharmacokinetics of CK-2127107 will be assessed. Astellas is conducting a Phase 1b clinical trial which is designed to assess the effect of CK-2127107 on skeletal muscle fatigue in approximately 60 subjects who are 70 to 89 years of age and who have limited mobility. Endpoints to be measured include the change from baseline versus 14 days of treatment in sum of peak torque during isokinetic knee extensions. Additionally, the trial will assess the effects of CK-2127107 on physical performance as well as assess the safety, tolerability and pharmacokinetics of CK-2127107. Cytokinetics is conducting FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS) which is expected to enroll 450 patients with ALS and is designed to assess the change from baseline in the percent predicted slow vital capacity (SVC) and other measures of skeletal muscle function after 12 weeks of treatment with CK-2127107. Secondary endpoints include the slope of the change from baseline in the mega-score of muscle strength measured by hand held dynamometry (HHD) and handgrip dynamometry in patients on CK-2127107; change from baseline in the ALS Functional Rating Scale – Revised (ALSFRS-R); incidence and severity of treatment-emergent adverse events (TEAEs); and plasma concentrations of CK-2127107 at sampled time points in the trial.
Cytokinetics, Incorporated is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The Company specializes in muscle biology and the mechanics of muscle performance. It is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Its cardiac muscle contractility program is focused on the cardiac sarcomere. Its clinical-stage drug candidates are: aficamten, which is a next-in-class cardiac myosin inhibitor; omecamtiv mecarbil, which is a cardiac myosin activator; CK-586, which is an additional cardiac myosin inhibitor, and CK-136, which is a cardiac troponin activator. CK-586 is designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction.