MSD has reported that the Phase II Cadence trial of Winrevair (sotatercept-csrk) for combined post- and precapillary pulmonary hypertension (CpcPH) caused by heart failure with preserved ejection fraction (HFpEF), met its primary endpoint.
The trial demonstrated a statistically significant decrease in pulmonary vascular resistance (PVR) at 24 weeks from baseline in comparison to placebo. The initial safety data aligned with earlier results for Winrevair.
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Cadence is a placebo-controlled, randomised, double-blind Phase II trial assessing Winrevair’s safety and efficacy in patients diagnosed with CpcPH due to HFpEF with New York Heart Association (NYHA) functional class II or III.
The study design included invasive haemodynamics, biomarker analysis, exercise capacity, and non-invasive imaging.
In the trial, 164 patients were randomised equally to placebo, 0.7mg/kg Winrevair, or 0.3mg/kg Winrevair during the treatment period.
There are currently no approved therapies for CpcPH due to HFpEF, which is seen as rare but possibly underdiagnosed.
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By GlobalDataMSD Research Laboratories global clinical development vice-president Dr Mahesh Patel said. “In this study, Winrevair improved pulmonary vascular resistance, an important haemodynamic measurement related to cardiac and pulmonary blood vessel function that has the potential to translate into improved outcomes for patients with combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction.
“The Cadence trial was designed as a proof-of-concept study to evaluate the pharmacological activity of Winrevair in a new patient population, with the goal of informing further Phase III development.”
MSD plans to present the results at a scientific congress and proceed to Phase III trials. Winrevair has been granted approval in more than 50 countries.
Prior to this, MSD announced positive Phase III Hyperion trial results that showed Winrevair reduced clinical worsening events by 76% compared to placebo in recently diagnosed adults with pulmonary arterial hypertension (PAH).
