GalaCTIC trial fails Amjin's new drug project to cut heart failure and return it to Cytokinetics

After more than a decade of working with Cytokinetics on heart failure drug trials, Amson has decided to end its partnership and 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 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 more significant 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, the drug did not reach the secondary end of the trial, and no statistically reduced time for cardiovascular death was observed.
, 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).
. Morgan analyst Cory Kasimov said Amjin'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, which 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