Merck plans Phase 3 Winrevair study after Phase 2 trial hits goal
Results show treatment reduces pulmonary vascular resistance
Merck is planning a Phase 3 trial testing Winrevair (sotatercept-csrk) in people with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF).
CpcPH is a form of pulmonary hypertension due to left heart disease, marked by elevated blood pressure in the vessels that carry blood from the heart through the lungs and also the vessels that carry oxygen-rich blood from the lungs back to the heart. HFpEF is a form of left heart disease where the left side of the heart contracts at a normal rate, but doesn’t adequately fill with blood between heartbeats.
Merck subsidiary Acceleron sponsored the Phase 2 study, CADENCE (NCT04945460), which tested Winrevair against a placebo in more than 160 people with CpcPH due to HFpEF. The main goal was to see if the treatment would reduce pulmonary vascular resistance (PVR), a measure of how difficult it is for blood to move from the heart through the lungs.
The study accomplished that, showing a “statistically significant and clinically meaningful reduction … from baseline at 24 weeks compared to placebo,” Merck said in a company press release. Merck also said Winrevair’s safety in the trial was consistent with the therapy’s established safety profile. The company didn’t give specifics, noting that details will be presented at a “future scientific congress.”
Proof-of-concept trial designed to inform further development
“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,” said Mahesh Patel, MD, vice president of global clinical development at Merck Research Laboratories.
Winrevair is approved to treat pulmonary arterial hypertension, a different form of PH. The therapy, administered by injection under the skin, is designed to reduce the activity of signaling molecules that drive the abnormal growth of blood vessel cells that leads to disease progression.
“In this study, WINREVAIR improved pulmonary vascular resistance, an important [blood flow] 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,” Patel said.
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