Cytokinetics, Inc. (CYTK)

[H2R]

PHASE 2 CLINICAL TRIAL OF OMECAMTIV MECARBIL IN JAPANESE SUBJECTS WITH HEART FAILURE

CYTOKINETICS ANNOUNCES START OF PHASE 2 CLINICAL TRIAL OF OMECAMTIV MECARBIL IN JAPANESE SUBJECTS WITH HEART FAILURE
SOUTH SAN FRANCISCO, Calif., April 04, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced the start of a double-blind, randomized, placebo-controlled, multi-center Phase 2 clinical trial to evaluate the safety, pharmacokinetics and efficacy of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction. 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.

“Advancing the clinical investigation of omecamtiv mecarbil in Japan represents an important step for our novel cardiac myosin activator program,” said Fady I. Malik, MD, PhD, Cytokinetics' Executive Vice President, Research and Development. “Omecamtiv mecarbil holds promise as a potential new treatment for patients with heart failure and we look forward to learning about its clinical application in Japanese patients.”

Phase 2 Clinical Trial Design

The ongoing Phase 2 clinical trial of omecamtiv mecarbil in Japan will evaluate approximately 80 subjects with chronic stable heart failure with reduced ejection fraction over 16 weeks randomized 1:1:1:1 to receive either placebo or omecamtiv mecarbil twice daily at 25 mg, 37.5 mg or 50 mg. Subjects randomized to 37.5 mg or 50 mg will be up-titrated using a PK-guided dose titration strategy. The primary objectives of the trial are to assess the pharmacokinetics, safety, and tolerability of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction. The secondary objective is to measure changes from baseline in systolic ejection time measured at week 16. Additional information can be found at clinicaltrials.gov.