On 30 August 2025, at the 75th European Society of Cardiology (ESC) conference held in Madrid, Spain, during an abstract session on the topic of biomarkers, Mingming Yang MD PhD presented data on omecamtiv mecarbil (OM) and red cell distribution width (RDW) in patients with heart failure (HF) and reduced ejection fraction (HFrEF). Yang focused on Cytokinetics’ omecamtiv mercarbil. The study aimed to assess the relationship between RDW and clinical characteristics and outcomes in patients with HFrEF, and to quantify the effect of OM according to baseline RDW in GALACTIC-HF.
The findings presented at ESC highlighted that RDW is an independent predictor of adverse outcomes in patients with HFrEF, providing incremental prognostic data beyond traditional risk factors and established biomarkers. The findings also support the use of RDW as a prognostic marker in standard clinical practice and in GALACTIC-HF. The benefit of OM was consistent across the range of RDW examined.
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OM is a novel cardiac myosin activator developed for HFrEF, targeting impaired myocardial contractility without increasing intracellular calcium, which differentiates it from traditional inotropes. The Phase III GALACTIC-HF trial demonstrated a modest but statistically significant reduction in the composite endpoint of cardiovascular death or first heart failure event compared with placebo, with greater benefit observed in patients with more severe heart failure (very low ejection fraction or hypotension). However, OM did not demonstrate improvements in mortality alone, quality of life or exercise capacity, and its overall clinical utility was limited by these modest benefits.
The US Food and Drug Administration ultimately declined to approve OM in 2023, citing insufficient evidence of clinically meaningful benefit versus risk, and required additional trials for reconsideration. A key opinion leader interviewed by GlobalData stated: “[OM] is a so-called cardiotonic drug and there is no drug that exerts a cardiotonic effect and has a long-term prognosis, so in that sense, I believe that it is unique, but the question remains regarding how many situations it is actually necessary. Situations where low cardiac output is strong and oral medication is necessary can be imagined, but I wonder how many of such situations actually exist.”
HF is a critical clinical condition in which structural and functional abnormalities in the heart impair its ability to meet systemic circulation. The various causes that contribute to these abnormalities are hypertension, arrythmia, valvular heart disease and risk factors including high cholesterol, infection and genetic factors. There is a strong opportunity in the HF space for new agents that could further reduce the incidence of HF-associated hospitalisations and mortality. According to GlobalData’s Pharma Intelligence Center Drug Database, Cytokinetics Inc has two drugs in development for HF: ulacamten in Phase II and omecamtiv mecarbil in Phase III.
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