The GALACTIC trial failed and the new drug project to cut heart failure was returned to Cytokinetics

After more than a decade of working with Cytokinetics on heart failure drug trials, Amjin has decided to end its partnership to return two heart failure treatment programs, omecamtiv mecarbil and AMG594, to Cytokinetics.
the termination of the partnership was mainly due to a less-than-expected Phase 3 study by omecamtiv mecarbil.
October, the two companies released key data from the GALACTIC-HF Phase 3 study.
The trial, a multi-center, double-blind, placebo-controlled trial, recruited a total of 8,256 patients with symptomatic, blood-shooting scores≤35 percent of patients with chronic heart failure who were randomly grouped to use omecamtiv mecarbil or a placebo based on standard heart failure therapies.
The trial eventually reached its main endpoint, and after 21.8 months of median follow-up, omecamtiv mecarbil statistically reduced the risk of the main complex endpoints of cardiovascular death or heart failure events (HR-0.92; 95%CI:0.86,0.99; p-0.025) compared to placebo.
results showed that omecamtiv mecarbil had a greater effect on patients with lower blood test scores.
, the greater the benefit of receiving omecamtiv mecarbil treatment in patients with heart failure with poor systolic function.
GALACTIC-HF trial, the overall safety of omecamtiv mecarbil appears to be consistent with the data from previous trials.
, however, did not reach the secondary endpoint of the trial, and no statistically significant decrease was observed in the time of cardiovascular death.
, 808 patients (19.6%) died in the omecamtiv mecarbil treatment group, while 798 patients (19.4%) in the placebo group died of cardiovascular disease (HR=1.01; 95% CI:0.92-1.11; p=0.86).
, an analyst at JPMorgan Chase, said amSm's test data were shocking and disappointing.
if the drug does not help heart failure patients live longer, it will raise doubts about the product's prospects, said Kasimov, a pharmaceutical company.
comes after high expectations for the future of the two heart failure drugs.
more influential omecamtiv mecarbil is a new selective cardiomyocytoglobulin activator that directly helps the heart contract.
another drug, AMG594, is a new type of selective cardiomyosin activator that is currently in the early stages of clinical development, with HFrEF and other types of heart failure as the main experimental indications.
Amgen has now returned two drugs to Cytokinetics, and the company is turning its attention to other cardiovascular stabilizers, including olpasiran (also known as AMG 890), a siRNA therapy for atherosclerotic heart disease that is currently in clinical development phase 2.
source: Amgen kicks heart failure med back to Cytokinetics after 'GALACTIC' flop