Cytokinetics (CYTK) Presents Additional COSMIC-HF Data; Possible Improvement in Symptoms Noted

September 19, 2016 7:33 AM EDT

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Cytokinetics, Inc. (Nasdaq: CYTK) announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented in a Rapid Fire Abstract Session at the 20th Annual Heart Failure Society of America Scientific Meeting in Orlando, FL. The results presented show that omecamtiv mecarbil may improve symptoms in patients with moderate to severe heart failure symptoms versus placebo after 20 weeks of double-blind treatment, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS), one of the sub-domains of a self-administered questionnaire that measures quality-of-life in patients with heart failure. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.

“It’s encouraging to see in these data that patients’ self-reported heart failure symptoms may have improved in association with improvements in cardiac function in those receiving omecamtiv mecarbil versus placebo,” said Fady I. Malik, MD, PhD, Cytokinetics' Executive Vice President, Research and Development. “We look forward to further investigating how these potential improvements may translate to clinical outcomes in our planned Phase 3 clinical trial to be conducted in collaboration with Amgen.

COSMIC-HF: Expansion Phase Design and Results

The expansion phase of COSMIC-HF evaluated the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil dosed as 25 mg twice daily or 25 mg twice daily with dose escalation to 50 mg twice daily, depending on a plasma concentration of omecamtiv mecarbil after two weeks of treatment. The study met its primary pharmacokinetic objective and showed statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group receiving pharmacokinetic-based dose titration. The results were initially presented as a Late-Breaking Clinical Trial at the American Heart Association (AHA) Scientific Sessions 2015. Additional results were also presented at Heart Failure 2016, the annual congress of the Heart Failure Association of the European Society of Cardiology, in May 2016, showing that omecamtiv mecarbil improved left ventricular (LV) systolic function, LV end-diastolic volume and NT-proBNP over time, suggesting potentially favorable ventricular remodeling and progressive reduction in myocardial wall stress.

The KCCQ TSS data from COSMIC-HF are shown in the table below. At week 20, the KCCQ TSS was increased (with increases in the score reflecting improvement) in a dose-related fashion, with a 4.9 point improvement in the PK-guided dose titration group (p=0.03). This improvement was greater among patients who were moderately to severely symptomatic at baseline, with the largest magnitude in the PK-guided dose titration treatment group (6.5, p=0.09). Patients who were asymptomatic or mildly symptomatic had modest improvements in the TSS.

Placebo OM 25 mg po BID OM PK-Titration
TSS-Overall (n)149150146
Baseline - Mean (SD) 69.7 (21.2) 70.9 (22.0)67.3 (21.3)
Change from baseline at Week 20 - Mean (SD)5.0 (1.6)6.6 (1.6)9.9 (1.6)
Difference vs. Placebo - Mean (95%CI)---1.7 (-2.8, 6.1)4.9 (0.5, 9.4)**
TSS-Group 1: Asymptomatic to Mildly Sx (n) 818675
Baseline - Mean (SD)77.3 (16.4)80.2 (18.3)78.4 (17.4)
Change from baseline at Week 20 - Mean (SD)1.6 (1.8)2.7 (2.0)4.3 (1.6)
Difference vs. Placebo - Mean (95%CI)---1.2 (-4.1, 6.4)2.7 (-2.2, 7.6)
TSS-Group 2: Moderately to Very Severely Sx (n) 676471
Baseline - Mean (SD)60.2 (22.6)58.3 (20.2)55.5 (18.7)
Change from baseline at Week 20 - Mean (SD)9.5 (2.7)11.3 (2.6)16.0 (2.7)
Difference vs. Placebo - Mean (95%CI)---1.8 (-5.7, 9.3)6.5 (-1.0, 14.0)*
(*p<0.10; **p<0.05)

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