Business
Cytokinetics Provides Clinical Trials and Business Update in Response to COVID-19 Pandemic
Top-line Results for GALACTIC-HF Expected in Q4 2020; Enrollment in METEORIC-HF Temporarily Suspended SOUTH SAN FRANCISCO, Calif., April 14, 2020 (GLOBE
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Top-line Results for GALACTIC-HF Expected in Q4 2020; Enrollment in METEORIC-HF Temporarily Suspended\nSOUTH SAN FRANCISCO, Calif., April 14, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today provided an update regarding the company's clinical trials and business operations related to its response to the COVID-19 pandemic alongside its commitment to prioritize the safety, health and wellbeing of patients, their caregivers, healthcare providers, partners and employees. The company believes it is on track to achieve its key strategic objectives for 2020. Cytokinetics continues to assess the potential impact of the pandemic on its pipeline and business operations and expects to provide further updates in connection with the reporting of its first quarter financial results in May.\n omecamtiv mecarbil (cardiac myosin activator) GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a large, Phase 3, global, event-driven, cardiovascular outcomes trial of omecamtiv mecarbil completed enrollment in mid-2019 with 8,256 participants in over 1,000 clinical sites. As previously reported, the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis of data from the trial, which included consideration of pre-specified criteria for futility and superiority. The DMC recommended that GALACTIC-HF continue without changes to its conduct. The study record for GALACTIC-HF was recently updated on www.clinicaltrials.gov to reflect an Estimated Study Completion Date of August 7, 2020. Cytokinetics expects results from GALACTIC-HF in Q4 2020. GALACTIC-HF is being conducted by Amgen in collaboration with Cytokinetics. METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a second Phase 3 clinical trial of omecamtiv mecarbil, is designed to enroll 270 participants. METEORIC-HF has enrolled participants at approximately 30 clinical sites in North America. Screening and enrollment of patients in METEORIC-HF have slowed in response to the COVID-19 pandemic. In consultation with the DMC, Cytokinetics and Amgen have agreed to temporarily suspend enrollment in METEORIC-HF to protect the safety and health of clinical trial participants and healthc...