Nov. 23, 2020: Amgen announced the Company has provided notice to Cytokinetics of termination of its collaboration and its intention 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 were recently presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine.
The trial 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 (heart failure hospitalization and other urgent treatment for heart failure) 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.
Amgen To Transition Development And Commercial Rights For Omecamtiv Mecarbil And AMG 594 To Cytokinetics