Merck's WINREVAIR Achieves Primary Endpoint in Phase 2 Study for Pulmonary Hypertension
- WINREVAIR showed significant reduction in pulmonary vascular resistance in Phase 2 CADENCE study.
- The study supports Phase 3 development for treating pulmonary hypertension due to HFpEF.
- Safety profile in CADENCE was consistent with known data for WINREVAIR.
- Results to be presented at a future scientific congress.
Study Overview
Merck announced positive results from the Phase 2 CADENCE study evaluating WINREVAIR (sotatercept-csrk) for treating combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF). The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) compared to placebo.
Clinical Implications
WINREVAIR demonstrated improved pulmonary vascular resistance, a key hemodynamic measurement related to cardiac and pulmonary blood vessel function. This improvement has the potential to translate into better outcomes for patients with CpcPH due to HFpEF.
Future Development
The CADENCE trial was designed as a proof-of-concept study to evaluate the pharmacological activity of WINREVAIR in a new patient population. The results will inform further Phase 3 development, and the company plans to present these findings at a future scientific congress.
Safety Profile
The safety profile observed in the CADENCE study was generally consistent with the known safety profile for WINREVAIR, supporting its continued development and potential future use in this patient population.
Source: Merck