Merck Reports Positive Phase 2 Results for Winrevair

Merck reported fresh momentum for Winrevair, releasing positive topline data from its phase 2 CADENCE trial in adults with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF).

The study delivered a clear win, showing a statistically significant drop in pulmonary vascular resistance (PVR) over 24 weeks compared with placebo.

According to Merck, the safety findings in CADENCE were generally in line with the known profile of Winrevair. The company highlighted the relevance of the hemodynamic improvements seen in this new patient group.

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“In this study, Winrevair improved pulmonary vascular resistance, an important hemodynamic 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,” said Dr. Mahesh Patel, vice president, global clinical development, Merck Research Laboratories.

CADENCE enrolled 164 adults diagnosed with CpcPH due to HFpEF and randomized them to placebo or one of two Winrevair dosing arms. The double-blind, placebo-controlled design focused on PVR as the primary endpoint while also tracking exercise capacity, biomarkers, imaging and clinical measures. The company plans to present full results at an upcoming scientific meeting and advance the program into phase 3.

Winrevair, already FDA-approved for pulmonary arterial hypertension (PAH), remains the first activin signalling inhibitor cleared to treat PAH. With no approved therapies for CpcPH, Merck’s progress signals a potential shift for a complex and underserved segment of pulmonary hypertension.