Amgen/Cytokinetics Phase III Heart Failure Data Are Below Expectations

Top-line results from the massive Phase III clinical trial of Amgen, Inc.’s and Cytokinetics, Inc.’s omecamtiv mecarbil in the treatment of heart failure with reduced ejection fraction (HFrEF) are mixed, at best. The initial data shared on 8 October showed that the GALACTIC-HF trial succeeded on the primary endpoint but a crucial secondary endpoint was missed, raising questions about whether the selective cardiac myosin activator can be approved and become a viable commercial product.

Omecamtiv met the 8,256-patient study’s primary composite endpoint of reduction in heart failure events (hospitalizations and other urgent treatments) and cardiovascular deaths with statistical significance versus placebo (HR: 0.92; 95%...