Cytokinetics (NASDAQ:CYTK) omecamtiv mecarbil received FDA fast track designation for the treatment of chronic heart failure with reduced ejection fraction (HFrEF).
Omecamtiv mecarbil is a novel selective cardiac myosin activator, or cardiac myotrope, designed to increase cardiac contractility. The drug candidate, which Cytokinetics is developing in collaboration with Amgen, is currently being evaluated in three Phase 3 clinical trials.
One of these studies, called GALACTIC-HF, is evaluating whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events and cardiovascular death in more than 8,000 patients with HFrEF. Topline results are expected in the fourth quarter of 2020.
“The prevalence of heart failure is growing with our aging demographics, and GALACTIC-HF is designed to assess the clinical effects of our novel myosin activator in patients meaningfully at risk,” Robert Blum, Cytokinetics’ president and CEO, said in a statement.
Dr. David Reese, Cytokinetics’ EVP of R&D, added, “Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition.”
