Cytokinetics, Inc. (CYTK)

[H2R]

POSITIVE RESULTS FROM PHASE 2 CLINICAL TRIAL OF OMECAMTIV MECARBIL IN JAPANESE PATIENTS WITH HEART FAILURE

http://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-positive-results-phase-2-clinical-trial

Company is Eligible to Earn $10 Million Milestone Payment from Amgenupon First Patient Dosing in Japan in Phase 3 Outcomes Trial

SOUTH SAN FRANCISCO, Calif., Aug. 02, 2017 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time (SET), a secondary endpoint. 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.

“We are pleased that this Phase 2 trial of omecamtiv mecarbil met its objectives in this population of Japanese heart failure patients,” said Fady I. Malik, MD, PhD, Cytokinetics' Executive Vice President, Research and Development. “The pharmacokinetics, pharmacodynamics, safety, and tolerability data from this trial were consistent with previously reported results from COSMIC-HF. We are now collaborating with Amgen on start-up activities for Japanese sites to participate in GALACTIC-HF.”

Cytokinetics is eligible to earn a $10 million milestone payment from Amgen upon the first dosing of a patient in Japan in GALACTIC-HF, the ongoing Phase 3 cardiovascular clinical outcomes trial of omecamtiv mecarbil.

Design of Phase 2 Clinical Trial in Japan

This Phase 2 clinical trial in Japanese patients with heart failure was designed to assess the pharmacokinetics of omecamtiv mecarbil as well as its effect on cardiac function, safety and tolerability in Japanese patients with chronic heart failure. The trial randomized 81 patients 1:1:1:1 to placebo, 25 mg of omecamtiv mecarbil twice daily and two separate PK-based titration groups in which the dose of omecamtiv mecarbil could be increased from 25 to 37.5 mg or 50 mg twice daily based on the pre-dose concentration of omecamtiv mecarbil at week 2. Patients received study drug for 16 weeks after randomization. The primary endpoint was to assess the plasma concentrations of omecamtiv mecarbil at weeks 2, 4, 12 and 16, and the area under the curve (AUC) at week 8. The secondary endpoint was to assess the change from baseline in SET measured by echocardiography at week 16.