Merck's Phase 2 CADENCE study in 164 adults with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) met its primary endpoint of reducing pulmonary vascular resistance (PVR) at week 24.
The 0.3 mg/kg dose reduced PVR by 1.02 Wood units (p=0.004) and improved six-minute walk distance by 20.3 meters, while the 0.7 mg/kg dose reduced PVR by 0.75 Wood units (p=0.024) with a non-significant 5.8-meter walk increase.
Merck indicated the 0.3 mg/kg dose optimizes the benefit-risk profile due to higher serious adverse events (33%) in the higher dose arm vs. 20% in the lower dose and 22% placebo.
Results presented March 29, 2026 at ACC.26 support advancing to Phase 3 registrational trials, with no approved treatments currently for CpcPH-HFpEF.
Lack of clear dose-response noted by analysts, possibly due to dropouts in the higher-dose arm.