Merck’s WINREVAIR Achieves Strong Phase 2 Results in CpcPH Linked To Heart Failure With Preserved Ejection Fraction , Advancing Toward Phase 3

Merck announced positive topline findings from its Phase 2 CADENCE study evaluating WINREVAIR™ (sotatercept-csrk) in adults with combined post- and precapillary pulmonary hypertension (CpcPH) caused by heart failure with preserved ejection fraction (HFpEF). The trial successfully achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in pulmonary vascular resistance at 24 weeks versus placebo. According to preliminary reviews, the safety results align with the established profile of WINREVAIR.

“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. “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 3 development.”

Merck plans to present the full CADENCE results at an upcoming scientific meeting and is preparing to advance the program into Phase 3. These findings potentially expand the therapeutic scope of WINREVAIR, which is already recognized for targeting activin signaling pathways involved in vascular remodeling and cardiopulmonary disease progression.

WINREVAIR is currently FDA-approved for treating adults with pulmonary arterial hypertension (PAH, WHO Group 1), where it has shown ability to improve exercise capacity, WHO functional class, and reduce risks of clinical worsening, including hospitalization, transplantation, and mortality. The therapy has secured approval in over 50 countries, and the CADENCE study marks an important step toward evaluating its utility in broader pulmonary hypertension populations, including those linked to HFpEF.