Amgen has terminated its collaboration with Cytokinetics and intends to transition the development and commercialization rights for omecamtiv mecarbil and AMG 594. Omecamtiv mecarbil, an investigational selective cardiac myosin activator, was studied in GALACTIC-HF, a Phase 3 clinical trial in patients with chronic heart failure with reduced ejection fraction (HFrEF), and AMG 594, a novel mechanism selective cardiac troponin activator, is in Phase 1 development for HFrEF and other types of heart failure.
Primary results of GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of time to CV death was observed.
"Cardiovascular disease is one of the most significant public health issues in the world which means patients need more innovation, not less. Our commitment to cardiovascular disease remains steadfast, and we look forward to continuing to work closely with the cardiovascular community as we focus on advancing our innovative therapies, including our Lp(a) inhibitor olpasiran (AMG 890), which is currently in Phase 2," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are grateful to the investigators and patients who participated in GALACTIC-HF. Unfortunately, the results of GALACTIC-HF did not meet the high bar we had set for the program."
Amgen thanks Cytokinetics and Servier for their productive collaboration over many years, and will work closely with them to facilitate a smooth transition of omecamtiv mecarbil. Servier provides funding and strategic support for the program.