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Merck & Co. Inc. (NYSE:MRK) on Tuesday released topline results from the Phase 2 CADENCE study of Winrevair (sotatercept-csrk) in adults for combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF).
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CADENCE met its primary endpoint, showing a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) from baseline at 24 weeks compared to placebo.
Based on a preliminary assessment, the safety profile observed in the CADENCE study was generally consistent with the known safety profile for Winrevair.
Also Read: Merck’s Winrevair Cuts Clinical Worsening Risk By 76% Among Hypertension Patients
“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 pre-capillary pulmonary hypertension due to heart failure with preserved ejection fraction,” said Dr. Mahesh Patel, vice president, global clinical development, Merck Research Laboratories.
The company is planning to present these results at a future scientific congress and intends to proceed with Phase 3 development.
In June, Merck announced positive topline results from the Phase 3 HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo.
Winrevair, added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH, demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events compared to placebo.
Winrevair is U.S. Food and Drug Administration (FDA) approved as an activin signaling inhibitor indicated for adults with pulmonary arterial hypertension to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.
MRK Price Action: MRK stock is up 4.70% at $97.22 at publication on Tuesday.
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