Amgen, in collaboration with Servier and Cytokinetics, is exploring the use of its novel therapeutic agent, omecamtiv mecarbil (OM), in patients with heart failure with reduced ejection fraction (HF-REF).
The results of the COSMIC-HF trial were discussed at the American Heart Association Scientific Sessions 2019 in Philadelphia, US. OM was seen to improve left ventricular systolic function while causing no worsening of diastolic function. Further successes in trials may add this novel therapy to the heart failure (HF) market, an area of longstanding unmet need.
The COSMIC-HF trial looked at the effects of OM in patients with stable but symptomatic HF. The trial included 448 patients, 82% of whom were male, and patients were given either twice-daily doses of 25mg OM (a second dose subset was up-titrated to 50mg OM twice daily) or placebo. Echocardiography was used to assess the effects of OM on diastolic filling and function.
Results have shown that OM caused a reduction in pulmonary pressure as well as causing an increase (<5ms) in isovolumic relaxation time (IVRT), signifying benefit on diastolic function. OM also improved left ventricular systolic function and size without worsening diastolic function.
In addition to COSMIC-HF, Amgen is currently running the METEORIC-HF Phase III trial to assess OM’s effects on exercise capacity of patients with HF-REF. The primary endpoint involves the change in peak oxygen uptake on cardio-pulmonary exercise testing between baseline measurements and measurements at Week 20.
GALACTIC-HF is another current Phase III outcomes trial assessing the effect of OM on cardiac outcomes. The primary endpoint, as with many other HF-REF trials, is time to cardiovascular (CV) death or first HF event. Patient inclusion criteria in the GALACTIC-HF trial include patients with a history of chronic HF and current hospitalization with a primary reason of HF or either hospitalization with the primary reason of HF or urgent visit to the emergency department within one year of screening. Both trials are aimed to complete in 2021.
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GlobalData believes that there is a place for OM within the current HF landscape, as it is a novel treatment with both improvements in diastolic function and potential improvements in exercise capacity, something that significantly impacts a patient’s quality of life.
Furthermore, the collaboration of Amgen, Servier, and Cytokinetics will greatly improve commercial opportunity and marketing for the drug. As a novel mechanism, OM may bring advantage over Novartis’ Entresto (sacubitril/valsartan), as many key opinion leaders (KOLs) believe that a novel mechanism of action will have better uptake than a drug similar to those already used, such as valsartan in Entresto. However, OM will face fierce competition for market share with sodium-glucose co-transporter-2 drugs, such as AstraZeneca’s Farxiga (dapagliflozin) and Boehringer Ingelheim’s Jardiance (empagliflozin) that are showing remarkable CV results in clinical trials.
GlobalData (2019) Heart Failure – Global Drug Forecast and Market Analysis to 2028, to be published